MAUDE Adverse Event Report: Integra MicroFrance S.A.S. HOOK HANDLE CEV229-1A DIA 5MM 350MM; Microfrance Instruments

Catalog Number	CEV229-1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports and is related to mfg number:3003249645-2026-00031 a facility reported that during a cholecystectomy, the hook handle cev229-1a dia 5mm 350mm (cev229-1a) "slipped out of its sheath, burning the sheath from the inside.This incident resulted in a liver injury, leading to the discontinuation of the hook's use." it was reported that the surgeon verified the integrity of the hook preoperatively and that it was intact.Per the report, "clinical consequence: moderate; there was current conduction and coagulation of an unintended area.".
Additional Manufacturer Narrative
The hook handle cev229-1a dia 5mm 350mm (cev229-1a) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the complaint concerns an assembly consisting of two parts: the cev229-1a handle and the cev2295a hook, which is screwed onto the handle.Damage was found on the handle's sheath.It has a cut at its end, as well as a second impact mark located slightly higher up.Scratches are also visible on the surface of the sheath.The electrical test failed.Root cause analysis: the analysis confirms that the damage to the sheath resulted from contact with a sharp object.This damage could have occurred during the surgical procedure through interaction with another instrument in the operating field, or during the cleaning and handling process in a basket containing sharp instruments.

• Brand Name: HOOK HANDLE CEV229-1A DIA 5MM 350MM
• 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 ; +1(609)936-2319
• MDR Report Key: 50101856
• Report Number: 3003249645-2026-00032
• Device Sequence Number: 15953361
• Product Code: GEI
• UDI-Device Identifier: 10381780092513
• UDI-Public: 10381780092513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: CEV229-1A
• Device Lot Number: 6843643
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown