MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BIPOLAR INSERT CEV633-1A 350MM BOTELLA; PFM16

Catalog Number CEV633-1A

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This report is 3 of 3, for the 350mm botella bipolar insert (cev633-1a) component of the forceps used during this event.This report is related to mfg report numbers: 3003249645-2023-00030 and 3003249645-2023-00031.It was reported that the staff heard a crackling during the use of the forceps.Towards the end of the procedure, the surgeon stated that his thumb gets hot when he uses the bipolar forceps.He noticed a superficial burn on his thumb when removing the gloves.It was reported that the device was in contact with a patient; however, no patient injury was recorded.A 10-minute delay in procedure occurred and another forceps was used.

Manufacturer Narrative

The 350mm botella bipolar insert (cev633-1a) was returned for evaluation: the device history record (dhr) for lot no.6504916 was reviewed and no anomalies that could be associated with the complaint were observed.Failure analysis: evaluation of the bipolar insert verified the complaint reported by the customer as valid.The insert did not pass electrical test.No visual damages on the coating between the jaws and the tube were found.There was no assembling issue with compliant handle.Root cause analysis: it was discovered that the device had a short circuit.There was a defect of coating under the tube, probably due to impurities.

Event Description

N/a.

• Brand Name: BIPOLAR INSERT CEV633-1A 350MM BOTELLA
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18108177
• MDR Text Key: 327868237
• Report Number: 3003249645-2023-00032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K210942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV633-1A
• Device Lot Number: 6504916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male