MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA; PFM16

Catalog Number CEV133

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Bowel Perforation (2668)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that a second surgery was necessary forty-eight (48) hours after the first surgery (cholecystectomy).The customer reported it was probably due to a defective device in the laparoscopy set.Complementary information received from the nurse on (b)(6) 2020 indicating that the first surgery was done without any issue seen by the medical staff.However the patient had a perforation on the small intestine, discovered post surgery.The patient needed a second surgery after two (2) days.The surgeon thought that the perforation was probably due to an electric arc between the forceps and the other instrument but the surgeon did not identify clearly in the laparoscopic set which device was responsible for the issue.Hence, they will send back all the devices and provide a list of devices and lot numbers from the set.

Event Description

N/a.

Manufacturer Narrative

The product was returned for evaluation.The coating was damaged near the jaws; there were scratches and the metal was visible.The device did not pass the electrical test.After disassembling, it was seen that the electrode was very dirty, it was soiled all along the tube and at the connection part.Device history record was reviewed and no anomalies that could be associated with the complaint were observed.The complaint was verified.The damages of the insulation could generate an electrical arc and lead to the reported event.These damages are due to improper cleaning of the device (use of scouring pad for example) despite of the recommendations of the instructions for use (ifu): "do not use abrasive cleaning products such as hard brushes, etc." and "check the cleanliness and operation of the instrument.Clean again if debris is present and remove from use any damaged instrument.Inspect components for any damage.If damage is observed, do not use the instrument until it is repaired.".

• Brand Name: FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA
• 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: 10367110
• MDR Text Key: 201708391
• Report Number: 2523190-2020-00088
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV133
• Device Lot Number: 2610655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEV10195R; CEV625-1; CEV649-5B; CP393-3