MAUDE Adverse Event Report: CONMED CORPORATION ABC BEND-A-BEAM HANDPIECE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 134006

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2022

Event Type  malfunction  

Event Description

About halfway through a liver transplant procedure (3 hours), the transplant fellow removed his finger from the button on the argon beam handpiece, which was 2-3 feet away from the patient's tissue.The fellow noticed that the tip of the device created a spark of about ½ of an inch.He immediately placed the device in sterile water.The surgical team removed the handpiece from the field and bagged it in its sterile packaging.The team noticed that the tip looked charred and melted.A new handpiece was obtained and used for the rest of the transplant procedure without any problems.There was no harm to the patient.Fda safety report id# (b)(4).

• Brand Name: ABC BEND-A-BEAM HANDPIECE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 14801791
• MDR Text Key: 294777523
• Report Number: MW5110495
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405002752
• UDI-Public: (01)30653405002752
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 134006
• Device Lot Number: 202201054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White