MAUDE Adverse Event Report: COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE; FER LIGATOR, HEMORRHOIDAL

Model Number	G34063
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
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
User such the internal hemorrhoids into barrel, then rotated the device to release the band.But user detected the released band was not spring back as expected.User then changed to another same device to complete the procedure.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.
Additional Manufacturer Narrative
Device evaluation: the hmbl-4-tri device of lot number c1908721 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 25th jan 2023.Lab evaluation date: 25/jan/2023.Visual inspection: anoscope, short shot returned.One band returned, deployed and shrunk as expected.Thread tracked on spool as expected.3 un-deployed bands present on device.Functional inspection: band deployed and shrunk as expected, spool rotates for deployment as expected.Documentation and ifu review: prior to distribution, all hmbl-4-tri devices are subjected to functional checks and visual inspection 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 the hmbl-4-tri devices of lot # c1908721did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1908721; upon review of complaints this failure mode has not occurred previously with this lot # c1908721.As per the instructions for use, ifu0030, users are advised of the following: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to joints, cracks or breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ the ifu states that ¿ maintain suction of haemorrhoid by keeping suction port covered.Deploy band by slowly rotating suction spool downwards until tension is released.¿ ¿uncover suction port of ligator to relieve suction on haemorrhoid.This will allow ligated haemorrhoid toe be released from tip of device.¿ there is no evidence to suggest that the customer did not follow the instructions for use.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 users technique during the procedure.It is possible that if suction was not released or too much tissue was sucked into the tip of the device, this may have caused the bands to slip off the haemorrhoid as the tissue may not have bulged around the band holding the bands in place,it may be noted that the bands were returned shrunk as expected.Further input was sought on band not springing back and it was clarified that the band did not shrink as expected.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.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
Supplement report being submitted due to the completion of the investigation 03-mar-2023.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include 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
Device evaluation: the hmbl-4-tri device of lot number c1908721 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 25th jan 2023.Visual inspection: anoscope, short shot returned.One band returned, deployed and shrunk as expected.Thread tracked on spool as expected.3 un-deployed bands present on device.Functional inspection: band deployed and shrunk as expected, spool rotates for deployment as expected.Documentation and ifu review: prior to distribution, all hmbl-4-tri devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.(d00059776[qsi0975], d00052026[prd0088] and d00055256[fqc0079].A review of the manufacturing records for the hmbl-4-tri devices of lot # c1908721did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1908721; upon review of complaints this failure mode has not occurred previously with this lot # c1908721.As per the instructions for use, ifu0030, users are advised of the following: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to joints, cracks or breaks.If an abnormality is detected that would prohibit proper working condition, do not use.There is not sufficient evidence to suggest that the user did not follow the instructions for use.Image review: n/a.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As the device functioned as intended when tested into a hand and no defect was observed, a possible root cause could be attributed to the fact that the bands were fired outside of the body on to a bench.Further input was sought on band not springing back and it was clarified that the band did not shrink as expected but this is not representative of operating conditions as the bands are designed to recover to their original size at body temperature.Summary: complaint is not confirmed as the failure could not be verified in the laboratory.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
Supplement correction report is being submitted due to the receipt of additional information resulting in an update to the investigation conclusions on 16-jun-2023.Imdrf codes corrected as follows: a0101 - patient-device incompatibility to a25 - no apparent adverse even.G04111 - ring to g07001 - part/component/sub-assembly term not applicable.C1303 - device difficult to operate to c19 - no device problem found.D02 - cause traced to component failure to d14 - no problem detected.

• Brand Name: SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
• Common Device Name: FER LIGATOR, HEMORRHOIDAL
• 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: 16014934
• Report Number: 3001845648-2022-00912
• Device Sequence Number: 6604776
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)230128(10)C1908721
• Combination Product (Y/N): N
• PMA/510(K) Number: K060623
• 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,Followup,Followup
• Report Date (Section B): 06/16/2023

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: 01/28/2023
• Device Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: C1908721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 11/24/2022; 11/24/2022; 11/24/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/21/2023; 03/30/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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