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

Catalog Number	BLB-024115
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event: dr (b)(6) performing a ureteroscopy with upper tract biopsy.The device would not open/close once it was in the scope and at the target site kidney.He proceeded with the case, using a cup biopsy forceps instead.No one was injured and the procedure was completed with a little extra time.Patient outcome: no one was injured and the procedure was completed with a little extra time.Patient/event info - notes: the following information has been received via email on 02aug2024.-please describe the exact location of the biopsy site.Kidney -did any section of the device detach and become free inside the patient? no -if not with the device in question, how was the procedure finished? cup biopsy forceps the following information has been requested via email on 02aug2024 / 23aug2024.1.What was the date of the occurrence? 2.On what date were you notified? 3.Will the facility be reporting this to a government agency (fda, competent authority, etc.) 4.Is an acknowledgment letter (formal notification of the complaint being received) required? 5.Is any account action needed (credit, no charge replacement, no action, investigation results, etc.¿)? 6.Will the product be returned? 7.Was the device functionality tested prior to use? 8.Were any other defects (other than the complaint issue) observed on the device prior to return (eg kink)? a.If yes, please specify what was observed and where on the device it was observed 9.Was the patient taking any anticoagulants or aspirin at the time of the procedure? 10.Was the anatomy tortuous? 11.What is the endoscope manufacturer and model number that was used? 12.Was the endoscope deflected at the time of the malfunction? 13.Was the endoscope in a curved or straight position? 14.Confirm that access sheath was used for procedure? 15.What type of suspicious tissue was being targeted for the biopsy, ie stalk or lesion? if other, please specify 16.How many biopsies were taken prior to this occurrence?.
Additional Manufacturer Narrative
Device evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.It had been indicated that the complaint device was going to be returned but to date this has not happened.If the device is returned in the future, then the file will be updated accordingly.Manufacturing records prior to distribution, all blb-024115 devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for blb-024115 of lot number c2158662 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 it should be noted that the instructions for use (ifu0034) 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 an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the user did not follow the ifu (ifu0034).Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause may be attributed to the user technique when using the device as it is possible that a slight kink or bend in the wire would have caused an issue when opening or closing the jaws of the device.Additionally, a possible root cause may be attributed to the scope being in a partially curved position as indicated in the additional information as it is known that the device was functioning prior to the procedure.¿was the device functionality tested prior to use? yes¿.Summary complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 15-jan-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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 20086634
• Report Number: 3001845648-2024-00534
• Device Sequence Number: 7688439
• Product Code: FCL
• UDI-Device Identifier: 10827002482408
• UDI-Public: (01)10827002482408(17)270403(10)C2158662
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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 Catalogue Number: BLB-024115
• Device Lot Number: C2158662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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