MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	CEV500T5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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
A facility reported that during a laparoscopic sleeve gastrectomy, the needle holder (b)(6) dia 5mm tungsten (b)(6) experienced a device failure in which the needle holder tip broke off and fell into the abdomen while suturing.The detached tip was located and retrieved without complication.A radiological examination (xray) was performed to verify complete retrieval.The incident extended the procedure by approximately 35 minutes.Another needle holder was used to complete the suturing.The patient is reported to be doing well, with no injuries or death associated with the event.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The needle holder cev500t5 dia 5mm tungsten (cev500t5) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the investigation shows that the movable jaw is broken at the front and rear.It was also observed that a break had occurred prior before the final break.These elements indicate a progressive degradation of the jaw before the final failure.Root cause analysis: the instrument was manufactured on february 28, 2022, acquired by the client in april 2022, and then repaired on july 23, 2024.During this repair, the tungsten plates on the jaws were replaced.This operation may have weakened the jaws.This initial weakening could have promoted progressive oxidation over the course of cleaning and reprocessing cycles.The oxidation further weakened the jaw structure.Under these conditions, the application of significant mechanical stress during the repair led to the instrument's breakage.The immediate cause was a mechanical stress exerted on the instrument during the procedure.The root cause was the weakening of the jaw during the repair, combined with the cumulative effects of successive cleanings leading to progressive oxidation.

• Brand Name: NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 23905846
• Report Number: 3003249645-2025-00058
• Device Sequence Number: 13265864
• Product Code: GCJ
• UDI-Device Identifier: 10381780093480
• UDI-Public: 10381780093480
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: CEV500T5
• Device Lot Number: 6210448 SAV 07-24
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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