MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. ANGLED HANDLE WITH RATCHET FOR 5MM DIAM. INSULATED TUBE; PFM16

Catalog Number	CEV10195CU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint is 1 of 2 for the handle (cev10195cu) component reportedly used during this event and is related to mfg number 3003249645-2025-00017: it was reported that during an operation, the surgeon noticed a loss of grip, making it impossible to resume gripping due to the absence of one of the fenestrated paddles.It was subsequently reported that the insert piece fell into the patient's abdomen.It was confirmed that all pieces were retrieved without any consequences to the patient.; no x-ray was required.It was reported that another forceps was used to finalize the surgery.
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.
Additional Manufacturer Narrative
Updated fields: the angle handle w/rachet (cev10195cu) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the handle did not verify the problem statement as valid.The reported issue concerns the insert (cev625t1u) used with this handle, reported under related mfg report# 3003249645-2025-00017.It was determined that the handle worked properly; there was no functional defect.
Event or Problem Description
N/a.

• Brand Name: ANGLED HANDLE WITH RATCHET FOR 5MM DIAM. INSULATED TUBE
• 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: 21961967
• Report Number: 3003249645-2025-00018
• Device Sequence Number: 13079946
• Product Code: GCJ
• UDI-Device Identifier: 10381780259114
• UDI-Public: 10381780259114
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: CEV10195CU
• Device Lot Number: 3520794
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2019
• 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