MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH; PFM16

Catalog Number	CEV604T1U
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
End user: (b)(6).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 the insert/5mm dia curved scissors insert for tube (cev604t1u) was defective; it was "tried on several handpieces but doesn't open or close." it was reported that the device was not in contact with a patient.Another instrument was used to finalize the procedure.No injury or death occurred; however, a 30-minute delay/prolongation in surgical time was reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The curved scissors insert (cev604t1u) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the returned curved scissors insert was in used condition.Tests were carried out upon receipt with the customer's tube and insert, as well as with ours and show the scissors cut well but there was resistance to closing the blades.Root cause analysis: the reported complaint was confirmed.It was determined that the pins were too dull.This was not noticed during prior service & repair evaluation, probably because of the lubrication provided.
Event or Problem Description
N/a.

• Brand Name: CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH
• 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: 21943537
• Report Number: 3003249645-2025-00016
• Device Sequence Number: 20970802
• Product Code: GCJ
• UDI-Device Identifier: 10381780428411
• UDI-Public: 10381780428411
• Combination Product (Y/N): N
• PMA/510(K) Number: K080257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: CEV604T1U
• Device Lot Number: 7327041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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