MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS LLC KIRWAN; APPARATUS, ELECTROSURGICAL

Model Number 30-5201

Device Problems Break (1069); Material Erosion (1214); Energy Output Problem (1431); Protective Measures Problem (3015)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

From operative report: due to extensive adenoid tissue i did release the mouth gag to allow for reperfusion of the tongue.I noticed at this point that the suction cautery was broken at the base of the flexible component where it attaches to the handle.I removed it off the field and it was at this point, i noticed a caustic injury of the right anterior oral tongue and the right inferior mucosal lip.The anterior commissure was spared.At no point did the tip of the suction monopolar cautery cauterize these tissues.I then inspected the suction monopolar cautery device itself and noticed that a portion of the blue insulation had been eroded with exposed metal.I assume that this was the cause of the caustic injuries as listed above.This portion of the suction cautery was not visible to me while i was performing the adenoidectomy.I then switched over to a previous model of suction monopolar cautery, the white and blue one with a larger lumen, to complete the adenoidectomy.The original suction monopolar cautery device was passed off for inspection and documentation.From staff: while doing a t&a the suction coagulator broke at the part it connects to the handpiece, which then caused the insulation to break down on the coagulator and the patient's tongue was burned on the right side.We were using a substitute coagulator as our normal ones have been on back order.The coagulator being used was the foot-controlled kirwan surgical monopolar coagulator 8 inch.A new and different coagulator was opened to the field.Dr.Placed 3 chromic sutures on the wounded area.

• Brand Name: KIRWAN
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS LLC; 180 enterprise dr; marshfield MA 02050
• MDR Report Key: 16860048
• MDR Text Key: 314472268
• Report Number: 16860048
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-5201
• Device Catalogue Number: 30-5201
• Device Lot Number: 221018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1825 DA
• Patient Sex: Male
• Patient Weight: 19 KG