MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. LARYNGOSCOPE MCL77 180MM LRG BOUCHAYER; LARYNGOSCOPE, RIGID

Catalog Number	MCL77
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The laryngoscope mcl77 180mm lrg bouchayer (mcl77) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the customer reported that the instrument caused minor bleeding in the patient's pharynx during the operation.This information was not communicated when it was sent for repair in june 2025.The finished good involved in the complaint had been in service for almost four years before being returned for service & repairs according to contract service, without any prior complaint.No additional complaints were identified for this lot or from other customers.Moreover, this lot, like all products manufactured, was subjected to 100% inspection during the manufacturing process.At the time of return to service & repairs, the customer did not report any soldering/brazing issues.During the repairs performed in june 2025, several operations were carried out, including polishing, finishing, and assembly.All of which are documented in the service & repair (s&r) device history record (dhr).While repairs could potentially contribute to the issue, external factors such as handling within the hospital, final cleaning, or sterilization could also have played a role.All repaired devices undergo 100% inspection, including visual and functional testing performed by a second operator.Based on these controls, the likelihood that the issue originated from the repair process is considered low.Root cause analysis: all repaired devices undergo 100% inspection, including visual and functional testing performed by a second operator.Based on these controls, the likelihood that the issue originated from the repair process is considered low.The root cause is undetermined.
Event or Problem Description
A facility reported that during a procedure, the laryngoscope mcl77 180mm lrg bouchayer (mcl77) had a defect that caused an injury to the pharynx, resulting in minor bleeding.It was also reported that the patient was well, and the surgical time increased by less than 30 minutes.

• Brand Name: LARYNGOSCOPE MCL77 180MM LRG BOUCHAYER
• Common Device Name: LARYNGOSCOPE, RIGID
• 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: 23795214
• Report Number: 3003249645-2025-00056
• Device Sequence Number: 5546567
• Product Code: CCW
• UDI-Device Identifier: 10381780106128
• UDI-Public: 10381780106128
• 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
• Report Date (Section B): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MCL77
• Device Lot Number: 5939033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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