MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS INSERT CEV605-3 3PK 350MM; PFM16

Catalog Number	CEV605-3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the 350mm scissors insert (cev605-3) during a cholecystectomy coelio, the blade came loose, broke, and fell into the patient.It was reported that the event led to a 15-minute increase in surgery time, and risk of losing the blade in the patient.It was reported that all parts were recovered from the patient, and the procedure was completed with the use of disposable scissors.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The 350mm scissors insert (cev605-3) were returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the scissors insert verified the problem statement as confirmed.One of the two blades were broken.The presence of rust at the breakage level was observed, which means that there was an incipient breakage before the final breakage.Root cause analysis: it was determined that the blade was weakened previously, perhaps by a shock from a fall or during cleaning.The blade being weakened gave way during use during surgery.This initial breakage can be seen by carefully observing the instrument before making it available for the operating room.

• Brand Name: SCISSORS INSERT CEV605-3 3PK 350MM
• Common Device Name: 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: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21732090
• Report Number: 3003249645-2025-00012
• Device Sequence Number: 4197092
• Product Code: GEI
• UDI-Device Identifier: 10381780094166
• UDI-Public: 10381780094166
• Combination Product (Y/N): N
• PMA/510(K) Number: K993655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CEV605-3
• Device Lot Number: 150301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown