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

Model Number	G48240
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
"device is a cup forceps.Something prohibiting the wire from going all the way back in the working channel of the hand piece.User could still open and close it but it wasn't working the way it should be.User couldn't hear a proper clicking as expected.Left kidney.".
Additional Manufacturer Narrative
Pma 510k#: class i n/a.Device evaluation: the blb-024115 device of lot number: c1730209 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 11 june 2021.On evaluation of the device there were no defects observed.The device functioned as intended.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: c1730209 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1730209.It should be noted that the instructions for use (ifu0034-7) 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.¿ "if the package is opened or damaged when received, do not use.Visually inspect the product to ensure no damage is occurred.If abnormality is detected that would prohibit working condition, do not use".¿ at the completion of the procedure, detach the handle according to instructions as follows: a) with the button depressed, retract the finger spool over the button.B) secure handle in this position by releasing the button (fig.2) the forceps shaft may now be removed from the handle.¿ and in step 7 ¿remove bigopsy forceps from endoscope.¿ there is not sufficient evidence to suggest that the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the handling of the device by the user.As the device functioned as expected in the cirl lab evaluation there is no device malfunction.Summary: the complaint is confirmed based on customer 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 potential emerging trends.
Event or Problem Description
Supplemental cancellation report being submitted due to the investigation findings no longer deeming this file reportable on (b)(6) 2023.
Additional Manufacturer Narrative
Pma 510k #class i n/a device evaluation the blb-024115 device of lot number c1730209 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2021.The returned device lab examination findings and observations can be referred through attached photos on evaluation of the device there were no defects observed.The device functioned as intended 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 c1730209 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1730209.It should be noted that the instructions for use (ifu0034) states the following: secure the handle to the forceps according to instructions as follows: a) with the button depressed, retract the finger spool over the the button.B)secure handle in this position by releasing the button (fig.2) the forceps shaft may now be introduced into the handle.C) feed the forceps shaft through the handle (fig.3a) when the forceps shaft is visible in the viewing window of the handle (fig.3b) press button to relase finger spool (fig.3c) this secures the forceps shaft in the handle.The instructions for use go on to say ¿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.¿ there is sufficient evidence to suggest that the user did not follow the ifu.Root cause review a definitive root cause could be determined from the available information provided to be user error while handling and preparing of the device, the user was asked to elaborate on what they meant when stating they couldn't hear a proper clicking as expected and they responded that it was the clique you usually here when you slide the gray portion back into the groove of the red button, confirming it¿s in place and the working channel is open to thread the wire of the forceps into the channel.From this we know the user did not release the button as stated in the ifu and the handle was not properly secured as the regular clicking sound when the handle is securely assembled was not observed.It should be further noted the device worked as expected when returned to the cirl lab.Summary the complaint is confirmed based on customer 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 potential emerging trends.

• 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: 16023749
• Report Number: 3001845648-2022-00920
• Device Sequence Number: 12500529
• Product Code: FCL
• UDI-Device Identifier: 10827002482408
• UDI-Public: (01)10827002482408(17)230506(10)C1730209
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: 05/06/2023
• Device Model Number: G48240
• Device Catalogue Number: BLB-024115
• Device Lot Number: C1730209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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: Male