MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV136 BIPOLAR 350MM GAYET; PFM16

Catalog Number CEV136

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Smoking (1585)

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

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2015 during a liver laparoscopy, water entered to the internal mechanism of the forceps (forceps are designed to be waterproof) and led to breakdown, smoke and heat.This is a recurrent failure that can have several consequences including the risk of burning the patient, if the forceps are ineffective there is risk of hemorrhage and the need to open several sterile boxes (3 to 4) for each surgery which increase medical fees.The forceps failed the electric tests.

Manufacturer Narrative

Three of 3 reports (other mfg report # 2523190-2015-00134 and 2523190-2015-00133) integra has completed their internal investigation on december 23, 2015.The investigation included: methods: evaluation of actual device.Review of device history records; review of complaints history; results: evaluation of returned device; the wires coating does not meet the manufacturing specifications.Dhr review; no nonconformity for this lot.Complaints history; no complaint for this lot.Conclusion: the instruments have been repaired / modified outside of microfrance by an external contractor no qualified by microfrance.This modification could have led to the reported breakdown, smoke and heat.

• Brand Name: FORCEPS CEV136 BIPOLAR 350MM GAYET
• 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: 5294276
• MDR Text Key: 34005417
• Report Number: 2523190-2015-00142
• 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,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV136
• Device Lot Number: 02-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2001
• 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