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

Model Number G34063

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 1 x used hmbl-4-tri device involved in this complaint was returned to cook (b)(4) for evaluation.The device related to this occurrence underwent a laboratory evaluation on 09 nov 2018.There were no defects presents on the anoscope.When returned 1 band remained on the device the other bands were also present with the device.In the lab the bands were put back onto the device to check if the device was functioning.The bands deployed during the lab by gently turning the ratchet, band deployed and returned to a small size quickly, band slightly twisted when it shrank down to small size.Documentation and ifu review: prior to distribution, all hmbl-4-tri devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cook (b)(4).A review of the manufacturing records for the hmbl device of lot # c1514068 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1514068 ; upon review of complaints this failure mode has not occurred previously with this lot # c1514068.It may be noted that according to instructions for use, ifu0030- 7, the user is instructed to: ¿visually inspect with particular attention to joints, cracks and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.As per step 5 of the instructions for use, ifu0030- 7, the user is instructed to ¿deploy band by slowly rotating spool downward until tension is released.¿ root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that the user rotated the spool too quickly, resulting in all the bands deploying at once.When deploying the bands it requires the user to gently deploy the bands so they don't roll off the device all at once.It is also possible that the bands may have got caught on the inside of the anoscope causing them to fire prematurely.Summary: this complaint is confirmed based on customer testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations, "when using the device, they would go to deploy the bands but would lose suction and they would roll off into the barrel of the device.After unsuccessful deploying any band, they opened a new device to complete the procedure successfully.".

• 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; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8173016
• MDR Text Key: 130625060
• Report Number: 3001845648-2018-00601
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)190626(10)C1514068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: C1514068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1