MAUDE Adverse Event Report: COOK IRELAND LTD BIGOPSY BACKLOADING BIOPSY FORCEPS; FCL FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	G48240
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k)#: class i n/a.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During a right retrograde endoscopic ureter pyelography and right jj catheter change in a 36-y ear-old patient, the ureteral biopsy forceps did not open.A second forceps was used to perform the operation.There were no clinical consequences for the patient.Condition of the device: preserved contaminated.Type of contamination: biological (body fluids, human tissue, respiratory gases, etc.).The device involved in this incident is available for expert examination.
Additional Manufacturer Narrative
Device evaluation 1 unit of lot c2017534 of blb-024115 was returned opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 22 january 2025 and a lab re-evaluation on 23 january 2025.Observations from the lab evaluation were as follows; spool device and coiled wired returned separately.Forceps jaws observed to be opened upon return.Jaws initially closed upon activation of handle but unable to open subsequently.Observations from the lab re-evaluation were as follows; removed coiled wired from the device and observed kink on wire approx.10cm from the distal tip of the wire attempted to open the forceps jaws on the device but unable to.The reported failure was observed.Manufacturing records prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the notes section of the instructions for use, ifu0034 which accompanies this device states the following; ¿after the handle is attached, ensure the operation of the biopsy cups before surgical introduction.Biopsy cups default to the closed position.To open the biopsy cups pull the finger spool towards the thumb ring.To close, push the finger spool forward.Note: biopsy cups need to be in the closed position before surgical introduction¿."visually inspect the product to ensure no damage has occurred.If the package is opened or damaged when received, do not use.If abnormality is detected that would prohibit working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0034).Image review an image was not returned for evaluation.Root cause analysis a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.The s/s coiled wire was found to be kinked at approximately 10 cm from the distal tip of the wire and this would likely have resulted in the forceps jaws being unable to open for the user.A possible cause for the kink to the s/s coil wire could be attributed to damage sustained during preparation, use or handling of the device, however, this cannot be conclusively determined.Summary complaint is confirmed based on visual and/or functional inspection.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another device was used to complete the procedure.Complaints of this nature will continue to be monitored for similar event.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 29-may-2025.

• Brand Name: BIGOPSY BACKLOADING BIOPSY FORCEPS
• Common Device Name: FCL FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IR 00000
• MDR Report Key: 20795016
• Report Number: 3001845648-2024-00697
• Device Sequence Number: 20524179
• Product Code: FCL
• UDI-Device Identifier: 10827002482408
• UDI-Public: (01)10827002482408(17)260120(10)C2017534
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: CLASS I N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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 Expiration Date: 01/20/2026
• Device Model Number: G48240
• Device Catalogue Number: BLB-024115
• Device Lot Number: C2017534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown