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	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On opening and utilizing 'short-shot', it was noted that only 2 rubber bands.Luckily there was another back up that was opened and used on the patient.The procedure was a success.______________________________ was the device expiry date checked prior to use of the device? > yes was the device stored in its original packaging? > yes please describe the storage conditions especially pertaining to temperature and light exposure.> product was used after it was delivered.Was the device tested prior to due by deploying a band? > no was the complaint issue identified prior to use? > no, it was identified during usage.Was alcohol applied to the device? > no please describe the location and type of site to be banded.> internal hemorrhoids were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? > no at what stage of the procedure was it first noted that only two rubber bands were present on the shortshot device (e.G., during device preparation, upon insertion, or during the procedure)? > during the procedure was an attempt made to deploy any of the bands before the issue was identified? if so, how many bands were successfully deployed, if any? > no were there any difficulties encountered during deployment or any observations that led to the identification of the issue? > no was the device inserted into the patient before the issue was identified? > yes if available, could you please provide a brief sequence of events describing how the issue was identified and the actions taken thereafter? > on opening and utilizing the short-shot, it was noticed that there were only 2 rubber bands.Luckily there was back up which was then opened for the patient.
Additional Manufacturer Narrative
F5 - (b)(4) investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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
• 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; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 50912843
• Report Number: 3001845648-2026-00397
• Device Sequence Number: 5778531
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: C2440496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Unknown