MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HANDLE CEV6385R DIA 5MM STR MONOPOLAR; PFM16

Catalog Number CEV6385R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Burn (1756)

Event Date 01/14/2022

Event Type  Injury  

Event Description

Four (4) additional devices were received from the customer for evaluation in relation to this event.This report is linked to previously reported mfg numbers: 3003249645-2022-00007, 3003249645-2022-00008 and 3003249645-2022-00009.This report is now 5 of 7 reports related to the suspected device used during this event and is linked to mfg report numbers: 3003249645-2022-00018, 3003249645-2022-00019, 3003249645-2022-00020.A facility reported that a patient was being treated for bilateral inguinal hernia by laparoscopy.During the surgery, the small intestine was burned even if it was not touched by the extremity of the monopolar handle (cev6385r).It was reported that either of the four (4) devices used could be responsible for the dysfunction.The devices were changed to continue the procedure.The small intestine was sutured.The suspected devices were visually checked, and no defects were observed.The devices were then isolated.No surgical delay or death was reported.

Manufacturer Narrative

The monopolar handle (cev6385r) were returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the monopolar handle was unable to conclusively verify the complaint reported by the customer as valid.Therefore, an investigation for cause was unable to be performed.The handle is not in contact with the small intestine, it is not related to the reported.The received device has been previously repaired outside of microfrance: there are etchings on the device.Root cause analysis: the reported event is not related to the returned monopolar handle; thus, this complaint is unconfirmed.However, the instrument has been repaired/modified outside of microfrance.This modification could weaken the instrument.

• Brand Name: HANDLE CEV6385R DIA 5MM STR MONOPOLAR
• 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: 14316350
• MDR Text Key: 294667882
• Report Number: 3003249645-2022-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV6385R
• Device Lot Number: 201007MF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2010
• 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 Age: 22 YR
• Patient Sex: Male