MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV405 FENESTRATED 350MM JOHANN; PFM16

Catalog Number CEV405

Device Problem Material Fragmentation (1261)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that intraoperatively, the fenestrated forceps cev405 broke in the abdomen of the patient with loss of the mobile jaw.A second surgery was necessary the same day to retrieve the broken part still in patient abdomen.The event led to an increase of surgery time about 2 hours which included intraoperative fluoroscopy and postoperative radiography.

Event Description

N/a.

Manufacturer Narrative

Device history record: the dhr was reviewed and no anomalies that could be associated with the complaint were observed.The forceps was returned for evaluation: failure analysis: the evaluation verified the complaint as valid.The mobile jaw was broken at the pin.The fragment was not returned.There were stains at the breakage area.This device was never returned for servicing.Root cause: considering the date of manufacture, the absence of servicing and the stains on the device, this issue is probably due to the repetitive uses and improper reprocessing.

• Brand Name: FORCEPS CEV405 FENESTRATED 350MM JOHANN
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11143013
• MDR Text Key: 226036638
• Report Number: 2523190-2021-00003
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV405
• Device Lot Number: 140605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1