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

Model Number 30-5200

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/23/2023

Event Type  malfunction  

Event Description

Cautery was being used for hemostasis in bring back tonsil bleed.Noted by surgeon that burn had occurred to right side of mouth/lip area.Concern for faulty supply as lip had not touched mouth or lip area.Cautery removed and bacitracin applied to burn.Device was hot to touch even when no cauterizing.

• Brand Name: KIRWAN
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS LLC; 180 enterprise dr; marshfield MA 02050
• MDR Report Key: 17994770
• MDR Text Key: 326389936
• Report Number: 17994770
• 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: 09/27/2023

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: 30-5200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• 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: 3285 DA
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: White