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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 & f4 (title): cn endoscopy e1 & f5 (phone): (b)(6).Device evaluation: the hmbl-4-tri device of product lot number c2378655 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution, all hmbl-4-tri devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for hmbl-4-tri of lot number c2378655 did not reveal any discrepancies that could have contributed to this complaint issue.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number.Review historical data: not applicable for use error complaints.Instructions for use and/label review: it should be noted that the instructions for (ifu0030) states the following: "deploy band by slowly rotating spool downward until tension is released.¿ there is evidence to suggest that the customer did not follow the instructions for use.From the additional information received, it is known that the user spun the spool on the handle too quickly.Image (clinical) review: clinical imaging was not returned for evaluation.Root cause analysis: a definitive root cause was established.The user has not complied with the requirements of the ifu and/label.Instructions for use (ifu0030) states the following: "deploy band by slowly rotating spool downward until tension is released.¿ from the information provided, it is known that the nurses stated that they believed that the spools on the handle were spun too quickly leading to the bands misfiring.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the complaint report, this complaint was raised based on answers from a previous complaint from the same entity and product issue captured as (b)(4).It captures the most recent incidents which occurred on 1st april when both banding kits misfired.Confirmed quantity of 02 devices, confirmed used.According to the initial reporter, no adverse effects on the patient have been reported.
Event or Problem Description
Most recent incidents which occurred on 1st april.Both banding kits misfired during anal hemorrhoid banding.Used the short shot successfully with a different lot c2384208.Patient/event info - notes: was the trigger cord wound onto the handle spool until taut? yes was the spool rotated slowly? i asked the nurses who were in the room for feedback, they believed the spool was rotated fast.How many bands were fired before the issue occurred? both nurses don't know how many bands deployed.

• 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: 25732237
• Report Number: 3001845648-2026-00270
• Device Sequence Number: 13365295
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)261218(10)C2378655
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 06/12/2026

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: C2378655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2026
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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