MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS LLC KIRWAN DISPOSABLE MONOPOLAR SUCTION COAGULATOR WITH RESECTOSCOPE PIN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	REF 30-
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to commencement of the adenoidectomy, a moist gauze was placed over the lip and intraoral mucosa for protection.The adenoids were identified and were ablated with the suction cautery device in the standard fashion.Toward the completion of the procedure, the surgeon noted a spark emanate at the level of the lip.At this point, the suction cautery was still protected from the lip with the moist gauze, the surgeon ceased cautery and removed the suction cautery device to reveal a burn on the lower lip and mucosa as well as skin.Inspection of the suction cautery device indicate a defect in the protective insulation in the cautery at approx the same location where the spark would have occurred.Equipment sequestered and all same lot number hand pieces removed from inventory.(b)(4) model ft10 s/n (b)(4) which is only 6 months old was inspected with no problems found.Fda safety report id# (b)(4).

• Brand Name: KIRWAN DISPOSABLE MONOPOLAR SUCTION COAGULATOR WITH RESECTOSCOPE PIN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS LLC ; mansfield MA 02050
• MDR Report Key: 9840404
• Report Number: MW5093781
• Device Sequence Number: 2533839
• Product Code: GEI
• UDI-Device Identifier: 00841019107393
• UDI-Public: (01)00841019107393(17)240701(10)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: REF 30-
• Device Lot Number: 190723
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Weight: 19