MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS MCEN42-1 100MM CVD RT ROUVIER; PFM11

Catalog Number	MCEN42-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a nasal endoscopy, the scissors from the scissors mcen42-1 100mm cvd rt rouvier (mcen42-1) broke, and a sharp metal part was missing when they got out form the patient's nasal cavity.An x-ray was taken, and the missing part was found on the patient's larynx, which was removed through laryngoscopy, using magill forceps.No injury or death reported; however, an increase in surgical time greater than 30 minutes was reported.
Additional Manufacturer Narrative
Updated fields: b6, d9, g3, g6, h1, h2, h3, h6, h6/f10 health effect: clinical code, h11.The needle scissors mcen42-1 100 mm cvd rt rouvier (mcen42-1) was not returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: upon evaluation, it was discovered that one of the two blades was broken.The manufacturing date was july of 1995, and the instrument was repaired at a location other than integra microfrance (imf), marking af04/24.Root cause analysis: the reported complaint was confirmed.The instrument is 30 years old and worn from use.According to the validation report (vr-imf-lifetime) revision b useful life of 3 years, equivalent to one use per week or approximately 50 uses per year.Based on this data, 150 tested cycles correspond to a useful life of 3 years.Furthermore, it was repaired outside of an imf.Imf recommends repairs within its factory and cannot guarantee the services provided by an external service provider.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h1 (type of reportable event), h2, h11.The h1 (type of reportable event) has been updated to "serious injury" to align with the initial mdr submission, ¿serious injury.¿.

• Brand Name: SCISSORS MCEN42-1 100MM CVD RT 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: 22436609
• Report Number: 3003249645-2025-00032
• Device Sequence Number: 17301111
• Product Code: LRW
• UDI-Device Identifier: 10381780103110
• UDI-Public: 10381780103110
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 09/12/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MCEN42-1
• Device Lot Number: 07-95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/30/2025; 09/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown