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

Model Number G34063

Device Problems Patient-Device Incompatibility (2682); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

User suck the haemorrhoids into barrel and rotate the device to release the band, but the band cannot be shrink. User then changed to another same 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. ".

Manufacturer Narrative

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
• Type of Device: FER LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12009766
• MDR Text Key: 281168920
• Report Number: 3001845648-2021-00500
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/15/2021
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/12/2021
• Device Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: CF1773440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial