MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS INSERT CEV605-1 350MM DIA 5MM; PFM16

Catalog Number	CEV605-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a laparoscopic rectosigmoid resection, with the release of the colic artery, the scissors insert cev605-1 350mm dia 5mm (cev605-1) scissors broke while cutting the artery.Additional information received by the customer reports that there was an increase in surgical time of less than 30 minutes to retrieve the broken pieces, and the surgery was completed without any complications.There were no reports of injury or death, or additional tests carried out during the procedure.
Additional Manufacturer Narrative
Additional information-root cause analysis: the breakage may result from an impact or excessive force applied to the instrument during use.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The scissors insert cev605-1 350mm dia 5mm (cev605-1) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: investigation findings showed a breakage at the heel of the blade.The blades do not appear to have been used to cut unsuitable material.The investigation does not show any material problem.The steps of the manufacturing instruction were respected.Root cause analysis: analysis of the incident has not identified a specific cause.To date, there is no evidence to suggest that this incident is linked to a systemic failure or a recurring trend.This is therefore an isolated case.

• Brand Name: SCISSORS INSERT CEV605-1 350MM DIA 5MM
• 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: 23393402
• Report Number: 3003249645-2025-00047
• Device Sequence Number: 9983789
• Product Code: GEI
• UDI-Device Identifier: 10381780094159
• UDI-Public: 10381780094159
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: CEV605-1
• Device Lot Number: 7402868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 12/09/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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