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	11/19/2024
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 one of the blades of the laparoscopic scissors/350mm dia 5mm scissors insert (cev605-1) broke in the patient's abdominal cavity.There was no immediate consequence to the patient.It was reported that the delay in intervention to replace the device and recover the missing part from the patient was inferior to 30 minutes.The entire instrument was reportedly removed.
Additional Manufacturer Narrative
The 350mm dia 5mm scissors insert (cev605-1) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation verified the complaint reported by the customer as valid.One of the blades was broken.Root cause analysis: precise observation shows the presence of a crack prior to breakage due to successive uses and cleaning.This weakness undoubtedly led to breakage during use.
Event or Problem Description
N/a.

• 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: 21032274
• Report Number: 3003249645-2024-00060
• Device Sequence Number: 15748159
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 5091015
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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