MAUDE Adverse Event Report: Integra MicroFrance S.A.S. RETRACTOR CEV416 FLEXIBLE DIA 5MM; Microfrance Instruments

Catalog Number	CEV416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
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 procedure, the retractor cev416 flexible dia 5mm (cev416) was introduced through a 5 mm trocar.The adjustment knob was tightened to shape the retractor and position it beneath the liver.A liver laceration occurred, requiring bipolar hemostasis and the use of hemostatic agents, followed by removal of the retractor.Upon removal, a fracture was observed at the distal hinge, revealing a sharp metal fragment that had caused the significant liver injury.\" it is unknown if the failure led to an increase in surgical time.

• Brand Name: RETRACTOR CEV416 FLEXIBLE DIA 5MM
• 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: 50721011
• Report Number: 3003249645-2026-00040
• Device Sequence Number: 20945016
• Product Code: GCJ
• UDI-Device Identifier: 10381780093046
• UDI-Public: 10381780093046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: CEV416
• Device Lot Number: 7570942
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 09/08/2025
• 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