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

Catalog Number BLB-024115

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

When wire was inserted into handle and locked into place, handle was too stiff to open and close - the device could not be opened.Customer opened another bigopsy with success.No description of event.Insufficient details from customer at the time of the complaint.Updated complaint form received.3/11/23.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on 16-jan-2024.

Manufacturer Narrative

Device evaluation the blb-024115 device of lot number c1894993 involved in this complaint was returned for evaluation open in its original packaging.With the information provided, a physical and a document based investigation was carried out.Lab evaluation the device involved in the complaint was evaluated in the laboratory.Visual inspection: device handle and coiled wire returned.No kinks observed on coiled wire.Functional inspection: device cups opens and close without resistance.Wire backloaded fully into viewing window.Handle actuates correctly.Manufacturing records 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 relevant manufacturing records for blb-024115 confirms the failure mode has not previously occurred for this work order of lot number c1894993.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number 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 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 circumstances of use within a clinical setting could not be replicated within the laboratory.A possible root cause may be attributed to the user technique when using the device.Additionally a possible root cause may be attributed to a difficult patient anatomy as it is known that the device was functioning prior to the procedure.¿was the device functionality tested prior to use? - yes¿.It may be noted that during the lab evaluation of the returned device it was noted that device functioned as intended.Corrective action/ correction complaints of this nature will continue to be monitored for similar events.Summary complaint is confirmed based on customer and/or rep testimony.According to the customer when the wire was inserted into handle and locked into place the handle was too stiff to open and close.A definitive root cause could not be determined from the available information as the circumstances of use within a clinical setting could not be replicated within the laboratory.A possible root cause may be attributed to the user technique when using the device.Additionally a possible root cause may be attributed to a difficult patient anatomy as it is known that the device was functioning prior to the procedure.¿was the device functionality tested prior to use? - yes¿.It may be noted that during the lab evaluation of the returned device it was noted that device functioned as intended.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.

• 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: 18261304
• MDR Text Key: 330663359
• Report Number: 3001845648-2023-00878
• Device Sequence Number: 1
• Product Code: FCL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLB-024115
• Device Lot Number: C1894993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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