MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. MOUTH GAG MCL206 MORINIERE; PFM11

Catalog Number	MCL206
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Tooth Fracture (2428); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right distal screw of the moriniere mouth gag (mcl206) "jammed during surgery"; the user was unable to advance the rack.The device had been lubricated, but "operated jerkily." the following information was subsequently reported: "complicated exposure, assistant too far away, no light in the mouth, ¿seized¿ molinière robot mouth opener, very difficult to handle, screw, unscrew.Requests a nasotracheal intubation; new nasotracheal intubation with edema and bleeding.Clamping over previous clamping.The molinière mouth opener remains stuck in the open position in the patient, very difficult to remove it.Result of the extempo: cancer cells on the tonsillar pillar.New attempt at exposure by lubricating the mouth opener with the anesthetists¿ silicone spray.Edema, bleeding, tooth breakage on the upper incisor (21) and gum wound, exposure made dangerous by the defective molinière mouth opener.No robot-assisted intervention, excision of the right tonsil only.Consequences: tumor excision not performed: change in therapeutic management (radiotherapy)." simple tonsillectomy and radiotherapy management was performed to complete the procedure as excision was not possible.
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: g3, g6, h2, h11.Additional field: h6 (type of investigation).Corrected fields: h6 (investigation findings 1, investigation conclusions 1).It was subsequently reported that "the customer insisted on the rust on the blades, she did not find it normal on new equipment and blamed our equipment." the integra sales rep later reported that while observing the staff clean the autoclaves, the customer explained that "the rust on the instruments came from an incorrect adjustment of the ph of the water; the water being too acidic." pictures of the instrument have been provided by the customer.Corrective actions related to the reported failure is currently underway.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b2, b5 (below), d9, g3, g6, h2, h3, h4, h6 (clinical code2, impact code, type of investigation, findings and conclusion), h11.Corrected field: b1, h1, h6 (clinical code1).Additional b5: the customer later reported that the "tooth breakage occurred during the use and blocking of the mouth retractor.It was necessary to force to succeed in removing the retractor from the patient's mouth since the retractor would no longer close.This also probably promoted the tongue edema (but not the only factor) because the compression was maintained longer than expected since the retractor could not be removed." customer reported that the moriniere mouth gag "should have been used with the da vinci robot, but in practice, given the difficulties of exposure, there was no robot-assisted gesture." evaluation findings: the moriniere mouth gag (mcl206) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the moriniere mouth gag verified the problem reported by the customer.During the investigation, several observations were noted without confirming the reported blocking problem.The tests conducted during the investigation were unable to reproduce the reported blockage; only a hard spot was detected (probably due to friction between the cylindrical rack and the handle).This was likely due to the fact that the test was not conducted under real-life operating conditions.The same constraints were not applied.The locking screw was not performing its fixation function.The mouth opener advance screw had a hard spot.Oxidation was present on all tongue depressors at the marking.Autoclave cycle tests were performed on samples to simulate the various cycles potentially experienced by oxidized tongue depressors.The validation determined one cycle per week.These instruments have therefore potentially been sterilized 33 times since june 13, 2024, the date of purchase by the facility.These tests show no oxidation on the samples.Root cause analysis: functional tests were performed during the final inspection to detect any possible jamming; however, rack jamming was unconfirmed.With regards to rubbing of the cylindrical rack in the handle (observed sticking point), the potential hypothesis is slightly loose finish during adjustment.The mcl206 is a complex instrument.During assembly, adjustment, and inspection it is difficult to detect this type of sticking point, a defect that remains subjective.Sticking point at the mouth opener advance screw is hypothesized to be due to lack of lubrication in accordance with customer instruction.The rack teeth are straight while the pinion teeth are inclined, which does not allow for optimal anchoring.With regards to oxidation of spatulas, the most likely hypothesis stems from the storage and drying location after autoclaving.The tests conducted did not reveal any defect.The instrument underwent passivation before being released onto the market.The final cleaning and sterilization processes have also been validated with satisfactory results, and the methods are specified in the instructions for use.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected fields: h6 (investigation findings 1, investigation conclusions 1).Root cause analysis: the findings observed during the investigation were unrelated to the problem reported by the client.
Event or Problem Description
N/a.

• Brand Name: MOUTH GAG MCL206 MORINIERE
• 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: 21504668
• Report Number: 3003249645-2025-00006
• Device Sequence Number: 4590761
• Product Code: KBN
• UDI-Device Identifier: 10381780105220
• UDI-Public: 10381780105220
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MCL206
• Device Lot Number: 7388702
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 04/01/2025; 01/09/2026
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/29/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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; Other
• Patient Sex: Unknown