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

Model Number G48240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Customer emailed to say that it was impossible to do biopsy.The item wouldn't 'activate,' it wouldn't open or close.They had to use a second packet of same item as this item was unusable."as per cc form": the surgeon opened the package, tested the grasper before introducing in the ureteroscope but the grasper didn't open.They needed to open another package to do the biopsy.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This supplemental report is being submitted due to completion of the investigation on the (b)(6) 2023.

Manufacturer Narrative

Device evaluation the blb-024115 device of lot number c1868500 involved in this complaint was not returned for evaluation to cirl.With the information provided, a document based investigation was carried out.Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation document review prior to distribution blb-024115 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for blb-024115 of lot number c1868500 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has previously occurred with the current lot number.The root cause of this additional file was user technique.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1868500.It should be noted that the instructions for use (ifu0034-8) 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 is 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 not sufficient evidence to suggest that the user did not follow the ifu.Image review n/a confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Root cause review a definitive root cause could not be determined from the available information.As the device was not returned for evaluation, a possible root cause can only be speculated.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 closing the jaws of the device.Summary complaint is confirmed based on customer and/or rep testimony.Failure identified - device resistance, 01 device confirmed prior to use.A definitive root cause could not be determined from the available information.As the device was not returned for evaluation, a possible root cause can only be speculated.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 closing the jaws of the device.It is also possible that damage occurred as a result of transportation/storage led to the complaint issue.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 potential emerging trends.

• Brand Name: BIGOPSY BACKLOADING BIOPSY FORCEPS
• Type of Device: 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: 17332951
• MDR Text Key: 319449377
• Report Number: 3001845648-2023-00555
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 10827002482408
• UDI-Public: (01)10827002482408(17)240917(10)C1868500
• Combination Product (y/n): N
• PMA/PMN Number: CLASS I N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48240
• Device Catalogue Number: BLB-024115
• Device Lot Number: C1868500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1