MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. CABLE CP393-2 4.5M BIPOLAR VALLEYLAB; PFM16

Catalog Number	CP393-2
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that upon inspection at the hospital, the 4.5m bipolar valleylab cable (cp393-2) was found to be "non-functional".It was later reported that the fault was discovered during surgery, which led to a surgical delay greater than 30 minutes.Another product was reportedly used to finalize the surgery.Clarification has been requested from the customer and is pending response.No patient injury 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.
Additional Manufacturer Narrative
The suspected 4.5m bipolar valleylab cable (cp393-2) was not returned for evaluation; therefore, an investigation for cause was unable to be performed.Lot number information was provided; manufacturing records were reviewed, and no non-conformances were detected during production; the cables passed all quality checks.The pictures provided by the customer does not show any anomaly on the cable.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CABLE CP393-2 4.5M BIPOLAR VALLEYLAB
• 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: 21708696
• Report Number: 3003249645-2025-00009
• Device Sequence Number: 15955104
• Product Code: GEI
• UDI-Device Identifier: 10381780099642
• UDI-Public: 10381780099642
• Combination Product (Y/N): N
• PMA/510(K) Number: K073450
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: CP393-2
• Device Lot Number: 22130690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2021
• 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