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

Catalog Number CEV405

Device Problems Arcing (2583); Insufficient Information (3190)

Patient Problems Perforation (2001); Bowel Perforation (2668)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that during a right colectomy by laparoscopy, an electric arc caused a small intestine perforation.The injury was not observed during procedure.The patient was treated in emergency and returned to intensive care department.The event lead to surgical delay, unknown for how long.No further information was provided.

Manufacturer Narrative

Integra has completed their internal investigation on november 9, 2017.No anomalies that could be associated with the complaint were observed no adverse trend - first occurrence of this risk for this device a complaint investigation (failure analysis) and determination of root cause is not possible as the complaint could not be verified due to lack of sample.

• 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
• 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: 7005653
• MDR Text Key: 91203488
• Report Number: 2523190-2017-00132
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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: 110606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2011
• 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
• Patient Outcome(s): Other