MAUDE Adverse Event Report: Integra MicroFrance S.A.S. SCISSORS INSERT CEV605-1 350MM DIA 5MM; Microfrance Instruments

Catalog Number	CEV605-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during a robot-assisted left segmental ureterectomy, the laparoscopic scissors broke inside the operative cavity.They were removed through the trocar without any difficulty; however, it is impossible to determine whether a metallic fragment of the scissors remained within the surgical site.The proper functioning of the scissors had been verified immediately preoperatively by the scrub nurse.Visual inspection of the abdominal cavity did not reveal any lesions; however, an infectious risk must be taken into consideration if a metallic fragment remained in the abdomen.The instrument was removed from the surgical field; upon inspection, a missing component was identified at the tip of the scissors and reported.The abdominal cavity was irrigated and suctioned, followed by a meticulous visual inspection of the surgical site.No injury, death, or surgical delay was reported.
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.

• Brand Name: SCISSORS INSERT CEV605-1 350MM 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: 50477678
• Report Number: 3003249645-2026-00034
• Device Sequence Number: 10112462
• Product Code: GEI
• UDI-Device Identifier: 10381780094159
• UDI-Public: 10381780094159
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: CEV605-1
• Device Lot Number: 6385843
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• 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