MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV134 BIPOLAR 350MM MOUIEL; PFM16

Catalog Number CEV134

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on september 30, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; there is a short-circuit between the electrode and the handle [electrical test on program #1 with n691 hipot tester and 2273 bipolar connector].The black plastic insulated part made of peek located on the proximal part of the device which supports the two connectors for electrical connection is burnt.Moreover the electrode is very dirty on the wire under the tube.Dhr review; no nonconformity for this lot.Complaints history; no complaint for this lot.Conclusion: the reported burns on the plastic part are likely the consequence of the formation of a short circuit with an electric arc inside the device due to the presence of humidity / residues in the connection zone.These electric arcs could entail sparks, smoke or cracking.

Event Description

Other mfg report #: 2523190-2016-00167.It was reported smoke from the connection part of the forceps.No humidity on the material as it was not used for two months.Device was sterilized 3 weeks before surgery and was stored in a container.The device was in contact with the patient however, no patient injury was reported and the event did not lead to surgical delay.

• Brand Name: FORCEPS CEV134 BIPOLAR 350MM MOUIEL
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6010722
• MDR Text Key: 56966096
• Report Number: 2523190-2016-00166
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV134
• Device Lot Number: 150402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2015
• 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