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	10/24/2022
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
As initially reported to customer relations: a female patient of unspecified age underwent an un specified procedure in which the bigopsy backloading biopsy forceps, g48240, was used.Pine ridge surgery center c37383-0 handed me [district manager] a defective bigopsy gun yesterday.They [medical staff] tried using it in a case on monday, (b)(6) 2022 and per the provider and tech it did not work, the customer is very familiar with operating the device so i would not claim this to be user error.The patient was a female, i [district manager] do not know the age.They [medical staff] opened a new bigopsy gun and it worked without problem.The provider was able to finish the case.No harm was done to the patient due to this incident.No parts of the device remained in the patents body.This will not be reported to the fda.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? did the patient require any additional procedures due to this occurrence? if yes, please describe.Did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.For all complaints ask: please describe the exact location of the biopsy site.I.E.Upper pole, mid pole, lower pole.Was the device functionality tested prior to use? n/a, yes, no.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.For occurrences during use (once in contact with endoscope), also ask: was the patient taking any anticoagulants or aspirin at the time of the procedure? n/a, yes, no.Was the anatomy tortuous? n/a, yes, no.What is the endoscope manufacturer and model number that was used? was the endoscope deflected at the time of the malfunction? n/a, yes, no.Was the endoscope in a curved or straight position? confirm that access sheath was used for procedure? n/a, yes, no.What type of suspicious tissue was being targeted for the biopsy, i.E.Stalk or lesion? if other, please specify.How many biopsies were taken prior to this occurrence? did any section of the device detach and become free inside the patient? no.If yes, did it remain inside the patient? n/a.If yes, was the detached portion of the device retrieved during the same procedure? n/a.If not retrieved during the same procedure, when was the detached portion of the device retrieved? n/a.If no, how was the detached portion removed from the patient? n/a.Did the patient require any additional procedures as a result of this event? n/a, yes, no.If yes, what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day if not with the device in question, how was the procedure finished? they opened a new bigospy gun and it worked without problem.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This follow up mdr is being submitted to capture additional information received on 01-dec-2022: the device would not open or close even when the provider pushed the wire all the way back into the device as he (the provider) usually does.
Additional Manufacturer Narrative
Device evaluation: 1 x blb-024115 of lot number c1912282 was returned to cirl for a lab evaluation.It was returned open and in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 25 jan 2023.In summary the following results were observed in the lab evaluation.Visual inspection: blb returned.Wire fully visible in window.Kink observed approximately 30cm from tip of device.Functional inspection: jaws does not open and close.Image review: n/a.Documents review including ifu 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 device of lot number c1912282 did not reveal any discrepancies that could have contributed to the issue.There is no evidence to suggest that this issue affects the entire lot # c1912282; upon review of complaints this failure mode has not occurred previously with this lot # c1912282.The instructions for use which accompanies this device instructs the user in step 3 to ¿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.¿ according to instructions for use the user is given the following advice: "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".The instructions for use which accompanies this device instructs the user in step 6 ¿ 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 (possible): a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.The s/s coiled wire was found to be kinked at approximately 30 cm along the wire and this resulted in the forceps jaws being unable to open and close correctly.A possible cause of this kinked 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 as the failure was verified in the laboratory.According to the information reported, the patient did not experience any adverse effects or additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 24-mar-23 and an update to the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to additional information from the lab evaluation on the 25 jan 2023.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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: 15886242
• Report Number: 3001845648-2022-00818
• Device Sequence Number: 17423891
• Product Code: FCL
• UDI-Device Identifier: 10827002482408
• UDI-Public: (01)10827002482408(17)250210(10)C1912282
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2023

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: 02/10/2025
• Device Model Number: G48240
• Device Catalogue Number: BLB-024115
• Device Lot Number: UNKNOWN
• 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: 10/24/2022
• Event Location: Home
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 11/04/2022; 11/04/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/22/2022; 02/17/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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