MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. VERY CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH (PK 3); MICROFRANCE INSTRUMENTS

Catalog Number	CEV605T3U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The very curved scissors insert for tube 5 mm diameter, 310 mm length (pk 3) (cev605t3u) was returned for evaluation.Failure analysis: investigation findings showed one of the two blades of the scissors was broken.A pre-break could be seen on one side.Root cause analysis: the instrument had been returned to customer service in june 2025 for a simple blade sharpening; no structural defects were detected at that time.Analysis of the complaint reveals the presence of a pre-existing crack, which weakened the instrument and led to the complete fracture of the blade during use.This pre-existing crack could have originated from an impact during cleaning or handling, or from natural aging of the instrument, a hypothesis that cannot be confirmed without the manufacturing date and the number of uses.The pre-existing crack, located at the base of the blades, was not visible to the naked eye.Therefore, it could not have been detected either during the service intervention in (b)(6) 2025, if it was already present at that time, or by the user during the preparation of the instrument before the intervention.
Event or Problem Description
A facility reported that the tip of the very curved scissors insert for tube 5 mm diameter, 310 mm length (pk 3) (cev605t3u) detached into the abdominal cavity during laparoscopy, and the detached part was successfully retrieved."there were no clinical consequences for the patient.The blade fragment was retrieved during the laparoscopic surgery.The procedure was completed using an equivalent pair of laparoscopic scissors retrieved from a different set.The surgical time was extended by the time required to retrieve the blade fragment from the abdomen, as well as the time to retrieve the other set from the operating room equipment.The users did not specify how many additional minutes were needed.They are currently unable to provide this information.Finally, no information was provided regarding a radiological image.".

• Brand Name: VERY CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH (PK 3)
• Common Device Name: MICROFRANCE INSTRUMENTS
• 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: 24234529
• Report Number: 3003249645-2026-00001
• Device Sequence Number: 15695895
• Product Code: GCJ
• UDI-Device Identifier: 10381780428442
• UDI-Public: 10381780428442
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: CEV605T3U
• Device Lot Number: SAV 06-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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