MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BIPOLAR FORCEPS MCO291 95MM W/TRAY; PFM11

Catalog Number MCO291

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that when they opened the packaging, the tips of the bipolar forceps (mco291) would not meet and the handle does not function at all.There was no patient involvement., but there was a delay in procedure for four (4) days.The device was never used or processed.Issue was identified right out of the box.

Manufacturer Narrative

Mco291 bipolar forceps was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.This issue may be due to an improper adjustment of the forceps, a bad handling during the packaging operations or a bad handling when opening the box at receipt.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.

• Brand Name: BIPOLAR FORCEPS MCO291 95MM W/TRAY
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11109335
• MDR Text Key: 226005623
• Report Number: 2523190-2020-00160
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO291
• Device Lot Number: 4981004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1