MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. KNIFE MCEN102 110MM MONOPOLAR ROUVIER; PFM11

Catalog Number	MCEN102
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was being treated by endonasal excision following a chondrosarcoma of the posterior nasal septum.During electrocoagulation, the plastic sheath of the coagulating tip of the 110mm monopolar rouvier knife (mcen102) began to melt and peel away from the tip of the instrument.It was reported that although there was "risk of plastic particle deposit on the mucous membrane and risk of coagulation of adjacent structure caused by removal of the sheath from the instrument", no deposit of plastic particles on the mucosa nor coagulation of adjacent structures occurred.Ultimately, there was no consequence to the patient, nor significant delay in surgical time.It was reported that the procedure went well.The surgeon did not need to reuse the instrument but used another method (coagulant aspiration) to achieve hemostasis at the end of the surgery.Additionally, it was noted that the instrument had been repaired by an external subcontractor, other than integra microfrance.
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: d4 (udi#), d9, g3, g6, h2, h3, h6, h11.The 110mm monopolar rouvier knife (mcen102) was returned for evaluation: failure analysis: evaluation of the monopolar rouvier knife verified the problem reported by the customer as confirmed.The blue coating was melted on the side of the tip that is in contact with the patient.The blue coating was not made by integra microfrance.Root cause analysis: integra microfrance recommends repairs within its factory and cannot guarantee the services provided by an external service provider.
Event or Problem Description
N/a.

• Brand Name: KNIFE MCEN102 110MM MONOPOLAR ROUVIER
• Common Device Name: PFM11
• 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: 21485982
• Report Number: 3003249645-2025-00005
• Device Sequence Number: 19863777
• Product Code: GEI
• UDI-Device Identifier: 10381780101628
• UDI-Public: 10381780101628
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: MCEN102
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 44 YR
• Patient Sex: Unknown