MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS INSERT CEV607 6PK DIA 5MM; PFM16

Catalog Number	CEV607
Medical Device Problem Code	Mechanics Altered (2984)
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 complete scissors owned by the hospital is fully functional; however, the inserts/6pk dia 5mm scissors insert (cev607) "go jerky." it was reported that the device was not in contact with a patient.Another instrument was used to finalize the procedure.It was reported that there was a 30-minute delay/prolongation in surgical time.
Additional Manufacturer Narrative
The scissors insert cev607 6pk dia 5mm (cev607) were returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned scissors insert cev607 6pk dia 5mm were in used condition.The evaluation of the cissors insert cev607 6pk dia 5mm showed scissors cut well but were hard to use and snagged.They also had marks and dents on the blades.Root cause analysis: the reported complaint was confirmed.The electrosurgical instruments are intended to remove tissue and/or control bleeding.The received scissors cut well but were hard to use and snagged.They have marks and dents on the blades.The scissors were probably used to cut objects that were too hard, which damaged the blades and created friction that made them difficult to use.
Event or Problem Description
N/a.

• Brand Name: SCISSORS INSERT CEV607 6PK 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: 21943320
• Report Number: 3003249645-2025-00015
• Device Sequence Number: 8799775
• Product Code: GEI
• UDI-Device Identifier: 10381780094241
• UDI-Public: 10381780094241
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: CEV607
• Device Lot Number: 7116820
• 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: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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