MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. VERY CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH (PK 3); N/A

Catalog Number CEV605T3U

Device Problem Fracture (1260)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the end part of the scissors broke inside the patient's abdomen when surgeon was cutting the tissue.The broken part was retrieved.No surgical delay reported and the procedure was completed with a replacement product.

Event Description

N/a.

Manufacturer Narrative

Device history record: dhr for lot no.3496281 was reviewed and no anomalies that could be associated with the complaint were observed.The scissors insert was returned for evaluation: failure analysis:the evaluation verified the complaint as valid.One of the blades was broken at the pin.However, the broken part was not returned.No material or manufacturing defect was found.Root cause: the defect is probably due to repetitive impacts or a bad handling of the device during the cleaning or the storage.

• Brand Name: VERY CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH (PK 3)
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11047209
• MDR Text Key: 222695993
• Report Number: 2523190-2020-00158
• 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
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV605T3U
• Device Lot Number: 3496281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1