MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. INSERT CEV625D FENESTRATED 350MM; PFM16

Catalog Number CEV625D

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 05/11/2022

Event Type  Injury  

Event Description

It was reported that the fenestrated insert (cev625d) of the forceps was too aggressive and led to several wounds of the small intestine during its mobilization (gastric bypass).The medical staff needed to do two stitches (sutures) on the small intestine at the lesions/wounds.The event led to an increase in surgery time of 10 minutes.No complications occurred thereafter.

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

This is 2 of 2 reports for the component of the forceps reportedly used during this event and is linked to mfg report number 3003249645-2022-00033.The fenestrated insert (cev625d) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the returned fenestrated insert verified the complaint reported by the customer as valid.The tightening of the insert was over specification.No traumatic part was found on the jaws.The product was previously repaired on october 2019, but the setting of the device was not modified.No further investigation or corrective action is required at this time.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: INSERT CEV625D FENESTRATED 350MM
• 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: 15084082
• MDR Text Key: 296382152
• Report Number: 3003249645-2022-00034
• 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: 09/23/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV625D
• Device Lot Number: 3317270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• 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