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); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
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 sucked the hemorrhoids in place and rotated the spool releasing the band, but the band has no elasticity.Band didn't shrink.Above is the description from (b)(4), during the same procedure user then took another lot# of same product and checked the function before use while found out the band didn't shrink.No use on patient.User changed another brand of similar 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.".
Event or Problem Description
This is a cancellation report.The investigation was completed on 03-nov-2020 and this complaint has been categorized as negative feedback and therefore, does not meet the reporting criteria as per report as per fda guidelines ¿medical device reporting for manufacturers (2016).Please refer to g and h for details of the investigation.
Additional Manufacturer Narrative
11 x hmbl-4-tri unused devices were returned and evaluated on (b)(6)2020.The device used during procedure was not returned a definitive root cause could not be determined from the available information.This complaint has been deemed to be negative feedback as per engineering input the simulated test that the user employed on the bands was not reflective of operation conditions."the bands have optimum elastic properties at body temperature.They are designed to recover to their original size at body temperature.Benchtop deployment is not representative of this".Therefore the video attached of the bands being deployed onto an open hand is not a good simulation of their use in the body.The band was not brought up to body temperature in this test manner.File no longer meets the fda reporting requirements as a malfunction report as the malfunction reported was not representative of actual use conditions and has been deemed negative feedback.

• 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
• MDR Report Key: 10087879
• Report Number: 3001845648-2020-00313
• Device Sequence Number: 2850218
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)200513(10)C1613060
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: C1613060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1