Alisa Yamasaki1,2, Neil Bhattacharyya2,3. 1. Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, U.S.A. 2. Department of Otolaryngology, Harvard Medical School, Boston, Massachusetts, U.S.A. 3. Division of Otolaryngology-Head and Neck Surgery, Brigham and Women's Hospital, Boston, Massachusetts, U.S.A.
Abstract
OBJECTIVES: To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common devices and patient/provider sequelae. STUDY DESIGN: Retrospective analysis of FDA database of device-related adverse events. METHODS: Data were extracted from the OpenFDA database for all adverse events reported for electrosurgical devices used in tonsillectomies from January 2008 to December 2017. Adverse events were classified by device, event type, etiology, complication severity, and patient disposition. RESULTS: Six hundred fifty-two adverse events were identified, with 195 events (30%) leading to known bodily injury to patient/provider. Device failure was the most common adverse event (202 events, 31%), followed by burns in 187 patient (98% of burns) and three provider events (2%). Burn injuries occurred most frequently with coblation devices (78 events, 42% of burns), monopolar electrocautery (48 events, 25%), and electrosurgical generators (23 events, 13%). Burn injuries most commonly occurred in the oral cavity (144 events, 76% of burn events) and were most commonly first-degree (28 events, 15%). Complications related to burns were managed conservatively for 36% of burn events (68 events), and secondary surgery was rarely required (8 events, 4%). Postoperative bleeding (173 events, 26%; 3 deaths) and intraoperative fire (73 events, 11%) were also reported. Device failures caused significant OR delay or cancellation in 17% of occurrences (35 events). CONCLUSION: Numerous complications may occur with various devices used during tonsillectomy and can result in significant patient/provider harm and sequelae. Surgeons must understand the nature of such complications to facilitate safe perioperative care and inform preoperative patient discussions. LEVEL OF EVIDENCE: NA Laryngoscope, 130:1138-1143, 2020.
OBJECTIVES: To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common devices and patient/provider sequelae. STUDY DESIGN: Retrospective analysis of FDA database of device-related adverse events. METHODS: Data were extracted from the OpenFDA database for all adverse events reported for electrosurgical devices used in tonsillectomies from January 2008 to December 2017. Adverse events were classified by device, event type, etiology, complication severity, and patient disposition. RESULTS: Six hundred fifty-two adverse events were identified, with 195 events (30%) leading to known bodily injury to patient/provider. Device failure was the most common adverse event (202 events, 31%), followed by burns in 187 patient (98% of burns) and three provider events (2%). Burn injuries occurred most frequently with coblation devices (78 events, 42% of burns), monopolar electrocautery (48 events, 25%), and electrosurgical generators (23 events, 13%). Burn injuries most commonly occurred in the oral cavity (144 events, 76% of burn events) and were most commonly first-degree (28 events, 15%). Complications related to burns were managed conservatively for 36% of burn events (68 events), and secondary surgery was rarely required (8 events, 4%). Postoperative bleeding (173 events, 26%; 3 deaths) and intraoperative fire (73 events, 11%) were also reported. Device failures caused significant OR delay or cancellation in 17% of occurrences (35 events). CONCLUSION: Numerous complications may occur with various devices used during tonsillectomy and can result in significant patient/provider harm and sequelae. Surgeons must understand the nature of such complications to facilitate safe perioperative care and inform preoperative patient discussions. LEVEL OF EVIDENCE: NA Laryngoscope, 130:1138-1143, 2020.
Authors: Esther Lee; Amir Elzomor; Sameh Boulos; Olivia Silva; Luke J Pasick; Daniel A Benito; Jane Tong; Philip Zapanta; Arjun S Joshi; Joseph F Goodman; Punam G Thakkar Journal: Proc (Bayl Univ Med Cent) Date: 2022-05-19