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

Model Number	G34063
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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
The bands deployed but did not remain on the tissue.Was the device expiry date checked prior to use of the device? yes- within expiry date.Expires only 2026- 10-22.Was the device stored in its original packaging? yes.Please describe the storage conditions especially pertaining to temperature and light exposure.Stored in theatre pharmacy/stock room.Temperature controlled/no direct sunlight.Was the device tested prior to due by deploying a band? no if not with the ligator in question, how was the procedure finished? a second cook ligator was opened to perform the procedure.If additional intervention was performed, was it during the same procedure as the device failure or was it scheduled for another day? second device used during same procedure- no second procedure required.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? no.

• Brand Name: SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
• Common Device Name: FER - ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 24874917
• Report Number: 3001845648-2026-00141
• Device Sequence Number: 8921418
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)261022(10)C2358199
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: C2358199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female