MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS MCL15 ALLIG LFT BOUCHAYER; PFM11

Catalog Number	MCL15
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
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 bioburden was found in the jaws of the allig lft bouchayer forceps (mcl15) when the integra sales specialist checked them in.The loaner pool instrument was unpacked and inspected and the contamination was discovered.The customer was made aware and cleaned the instrument before use at the hospital.No patient injury or surgical delay was reported.
Additional Manufacturer Narrative
The alligator left bouchayer forceps (mcl15) was returned for evaluation: the device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.Failure analysis: the alligator left bouchayer forceps was returned in used condition with rust/staining on the etchings, along the barrel and between the jaws.Bioburden could not be located.The reported complaint could not be confirmed.Root cause analysis: the alligator left bouchayer forceps was received with rust/staining between the jaws which may have been mistaken for bioburden.Loaner pool records show decontamination and inspection prior to release.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: FORCEPS MCL15 ALLIG LFT BOUCHAYER
• 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 ; 6099362319
• MDR Report Key: 17566563
• Report Number: 3003249645-2023-00023
• Device Sequence Number: 17808722
• Product Code: GEI
• UDI-Device Identifier: 10381780105053
• UDI-Public: 10381780105053
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: Other
• Device Catalogue Number: MCL15
• Device Lot Number: D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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