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

Catalog Number HMBL-4-TRI

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Image review: images were provided of the device showing some black bands that had slipped off the hemorrhoid and retained inside the barrel.Document review including ifu review: prior to distribution hmbl-4-tri devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The lot number for this file is unknown, however, c1593598 has been provided as a possible lot number and therefore will be reviewed as part of the investigation.A review of the manufacturing records for hmbl-4-tri of lot number c1593598 did or did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has or has not previously occurred with the current lot number.Based on the information available to date, there is evidence or no evidence to suggest that there are any manufacturing issues associated with lot number c1593598.The shortshot saeed hemorrhoidal multiband ligator with triview anoscope is used to ligate haemorrhoids facilitated by an anoscope.As per the instructions for use, ifu0030-7, users are advised of the following: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to joints, cracks or breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ the ifu states that "the device may be used with an alternative anoscope if preferred.If an alternative endoscope is used, please consult relevant packaging, label and instructions for use".However, as a precaution, it is recommended that the "inner lumen diameter of the anoscope must be compatible with shortshot maneuvers within lumen of alternative anoscope with adequate clearance to avoid dislodging bands".In addition, "banding should begin at the most proximal location from the anal sphincter and proceed distally because passing shortshot over a previously placed band may dislodge the band".Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to user technique; if suction was not released or too much tissue was sucked into the tip of the device, this may have caused the bands to slip off the haemorrhoid as the tissue may not have bulged around the band holding the bands in place, or if the user did not begin at the most proximal location from the anal sphincter and proceed distally resulting in passing the shortshot over a previously placed band this may dislodge the band.Another possible cause for this complaint may be that the device was damaged during transportation or storage.However, as the conditions of transport or storage are unknown, it is not possible to conclusively determine this as a root cause of the complaint.Summary: the complaint is confirmed based on the customer's 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: "customer reported hemorrhoid bander issues to [dm].Customer and dm believe, based on usage, that it is a suction issue with the "cap"; when they go to deploy a band the band slips off the hemorrhoid.Procedures were all completed with additional devices from the same gpn.".

• 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: 8816338
• MDR Text Key: 151877382
• Report Number: 3001845648-2019-00354
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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