MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ROTO-LOK HUNTER BOWEL/LL 37CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	625164LL
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspecting the roto-lok hunter bowel/ll 37cm (625164ll), a significant amount of bioburden was still stuck in the jaws.It was reported that the instrument was a consignment request and was not used in a procedure.
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
The suspected roto-lok hunter bowel/ll (625164ll) was returned for evaluation.The device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.Failure analysis - the (loaner pool) roto-lok hunter bowel/ll was received in used condition.The product was cleaned and sterilized upon return; however, debris/bioburden was visible in the provided image.Decontamination history showed the product was sterilized upon its last return.Debris/bioburden between the jaws may be the result the jaws being left closed during sterilization.Per insert card provided with loaner items: "this surgical instrument is supplied non-sterile.Please use your hospital protocol for pre- and post- surgery decontamination and sterilization." root cause - the reported complaint was confirmed.Based on the provided images, this grasper was in used condition with debris or bioburden between the jaws due to incomplete cleaning/decontamination at the loaner pool.Loaner instruments are provided non-sterile and must be decontaminated/sterilized prior to use.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: ROTO-LOK HUNTER BOWEL/LL 37CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19244003
• Report Number: 3014334038-2024-00086
• Device Sequence Number: 6949140
• Product Code: GCJ
• UDI-Device Identifier: 10381780147343
• UDI-Public: 10381780147343
• Combination Product (Y/N): N
• PMA/510(K) Number: K931928
• 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): 09/24/2024

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: 625164LL
• Device Lot Number: 042915A
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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