MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. AFORCEPS MCL19 LEFT BOUCHAYER HEART; MICROFRANCE INSTRUMENTS

Catalog Number	MCL19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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
An intensive care unit reported that during a suspension laryngoscopy, the aforceps mcl19 left bouchayer heart (mcl19) from microsurgery kit number one broke inside the patient¿s larynx.The procedure time was extended due to the search for the broken fragment.It is unknown whether the fragment was retrieved.No injury or death was reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The aforceps mcl19 left bouchayer heart (mcl19) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: a clear break was visible on the lower part of the movable jaw window.Root cause analysis: the instrument was manufactured on august 30, 2018, and acquired by the customer on (b)(6) 2018.The instrument appears to have been used for approximately seven years without being serviced by integra microfrance (imf) during this period.No other complaints have been reported for this batch (12 units manufactured).A 100% inspection was performed at the end of production with no non-conformities detected in the final product.The breakage is explained by seven years of repeated use.

• Brand Name: AFORCEPS MCL19 LEFT BOUCHAYER HEART
• Common Device Name: MICROFRANCE INSTRUMENTS
• 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: 23943167
• Report Number: 3003249645-2025-00059
• Device Sequence Number: 15422470
• Product Code: GEI
• UDI-Device Identifier: 10381780105138
• UDI-Public: 10381780105138
• Combination Product (Y/N): N
• PMA/510(K) Number: K993655
• 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): 02/04/2026

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: MCL19
• Device Lot Number: 2950979
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2018
• 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