MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. INSERT CEV625-1 FENESTRATED 350MM; PFM16

Catalog Number	CEV625-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insert cev625-1 fenestrated 350mm (cev625-1) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The device history record (dhr) was not reviewed because the batch number was not available.An investigation for cause was unable to be performed because the device was thrown away after sterilization by the user.Potential root cause: the device may have been weakened by successive use and cleaning (five years), and this was not checked before being put into service for the operating room.
Event or Problem Description
A facility reported that during a laparoscopic procedure, the jaws of the insert cev625-1 fenestrated 350mm (cev625-1) broke when the surgeon was handling it and fell into the patient's abdominal cavity intraoperatively.An x-ray was carried out to find and extract it, at the request of the surgeon.It was reported that there was an increase in surgical time by more than an hour, time to take an x-ray, remove the device, and retrieve another sterilization box to obtain another pair of forceps.There was no patient death or injuries; however, an increase in surgical time greater than an hour was reported.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: d9: device available for eval.
Event or Problem Description
N/a.

• Brand Name: INSERT CEV625-1 FENESTRATED 350MM
• Common Device Name: PFM16
• 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: 22682542
• Report Number: 3003249645-2025-00035
• Device Sequence Number: 13023664
• Product Code: GEI
• UDI-Device Identifier: 10381780094494
• UDI-Public: 10381780094494
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: CEV625-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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