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	06/15/2026
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
Description of event email- this is the same doctor that has previous issues and re-training, it appears, he is spinning the thumb wheel to aggressively and quickly for it to ¿misfire¿ this is user error.Complaint form- the shortshot appeared to miss fire of the during haemorrhoid banding.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 13-aug-2026.
Additional Manufacturer Narrative
Supplemental report is being submitted due to the completion of the investigation on 13-aug-2026.__________________________________________ investigation - evaluation 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.Device evaluation: the hmbl-4-tri device of product lot number c2403926 involved in this complaint was returned for evaluation.With the information provided, a physical examination and document-based investigation was conducted.The devices related to this occurrence underwent a laboratory evaluation on the 23rd july 2026.On evaluation of the devices the following observations were made: visual inspection: hmbl handle returned.1 band returned separately.Handle examined and thread observed to be intact on spool.Functional inspection: spool rotates as expected.The reported failure was observed.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: not applicable for use error complaints as per d00059858 - table 1 - investigation requirements.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.As per description of event "this is the same doctor that has previous issues and re-training, it appears, he is spinning the thumb wheel to aggressively and quickly for it to ¿misfire¿ this is user error." 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 (ifu0030) states the following: "deploy band by slowly rotating spool downward until tension is released.¿ as per description of event "this is the same doctor that has previous issues and re-training, it appears, he is spinning the thumb wheel to aggressively and quickly for it to ¿misfire¿ this is user error." 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,¿misfire¿ has been reported.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, no adverse effects on the patient have been reported.

• 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 V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 25793479
• Report Number: 3001845648-2026-00274
• Device Sequence Number: 17614811
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)270304(10)C2403926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: C2403926
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2026
• 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