MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TONGUE DEPRESSOR MCL206A5 35X65MM; PFM11

Catalog Number	MCL206A5
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during a trans-oral-robotic surgery, a mouth gag was placed using the tongue depressor mcl206a5 35x65mm (mcl206a5) and the suspension apparatus.It was reported that, at the conclusion of the surgery, the mouth gag was removed, and there were two small lacerations on the patient's tongue, which were believed to be caused by the rounded corners of the mcl206a5 solid tongue blade, which required a couple of stitches in both locations to close and prevent further bleeding.No death or surgical delay 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
Updated fields: d9, g3, g6, h2, h3, h6, h11.The tongue depressor 35x65mm (mcl206a5) was not returned for evaluation after three good faith effort (gfe) attempts were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause may be the use of a device with damaged corners (bad handling by the customer or a manufacturing defect).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: TONGUE DEPRESSOR MCL206A5 35X65MM
• 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: 22439195
• Report Number: 3003249645-2025-00033
• Device Sequence Number: 3152635
• Product Code: KBL
• UDI-Device Identifier: 10381780105275
• UDI-Public: 10381780105275
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: MCL206A5
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Unknown