MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV515M ALLIG JAWS 15MM; PFM16

Catalog Number CEV515M

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

This is 2 of 3 reports for the alligator jaws forceps used during this event and is linked to mfg report numbers: 3003249645-2022-00007 and 3003249645-2022-00009.A facility reported that a patient was being treated for bilateral inguinal hernia by laparoscopy.During the surgery, the small intestine was burnt even if it was not touched by the extremity of the alligator jaws forceps (cev515m).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.

Manufacturer Narrative

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

Manufacturer Narrative

The alligator jaws forceps (cev515m) 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 alligator jaws forceps was unable to conclusively verify the complaint reported by the customer as valid.Therefore, an investigation for cause was unable to be performed.The received device has been previously repaired outside of microfrance: the insulation is not from microfrance, the jaws are welded and there are etching on the device.The device is not compliant with integra microfrance specifications.Root cause analysis: the alligator jaws forceps has been repaired/modified outside of microfrance.This modification could have weakened the instrument and led to the reported event.

Event Description

N/a.

• Brand Name: FORCEPS CEV515M ALLIG JAWS 15MM
• 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: 13803016
• MDR Text Key: 292389640
• Report Number: 3003249645-2022-00008
• 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,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV515M
• Device Lot Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• 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