MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK HANDLE CEV229-1A DIA 5MM 350MM; PFM16

Catalog Number CEV229-1A

Device Problem Peeled/Delaminated (1454)

Patient Problem Peritonitis (2252)

Event Date 01/13/2021

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 2 of 2 linked to mfg report number 2523190-2021-00040: a facility reported that during an unspecified procedure, the hook handle cev229-1a had a damaged insulation coating.There was patient impact of biliary peritonitis on thermal wound of the common bile duct requiring a second urgent surgery to be performed.The dysfunction was observed after the procedure.No delay in surgery was reported.

Manufacturer Narrative

The hook handle cev229-1a was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The root cause(s) of the difficulty reported by the customer could not be determined; however, the issue may be due to a bad handling of the device during the use or the reprocessing.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: HOOK HANDLE CEV229-1A DIA 5MM 350MM
• 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: 11389496
• MDR Text Key: 233977906
• Report Number: 2523190-2021-00041
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV229-1A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1