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 Unclear Information (4052)

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

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "i would like to register a complaint for short shot at (b)(6) hospital (b)(4).Please let me know if you need additional information." additional information provided by (b)(6) on 30apr2019: "the physician attempted to band the hemorrhoids, but the device seemed to deflate the hemorrhoids.I filled out everything that i know about the procedure.".

Event Description

This report is being submitted as a cancellation report.Additional information revealed no serious injury occurred and on clinical review user error was determined.The events do not meet the criteria of an fda mdr report.As reported to customer relations: "i would like to register a complaint for short shot at (b)(6) hospital (b)(6).Please let me know if you need additional information." additional information provided by dm on 30apr2019: "the physician attempted to band the hemorrhoids, but the device seemed to deflate the hemorrhoids.I filled out everything that i know about the procedure.".

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the device was not returned therefore a document based review will be performed.Documents 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.A review of the manufacturing records for hmbl-4-tri of unknown lot number could not be completed.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 stated in the ifu0030-7 "preparation 1.Anoscope - prior to procedure, test manoeuvrability of shortshot barrel in lumen of anoscope." ¿prepration 2.Ligation bander ¿ connect suction tube from suction unit to graduated connector at bottom of ligator of handle.Place finger on suction port and verify suction is present at tip of ligator barrel.Ensure settings on suction unit are appropriate for suction of hemorrhoids into tip of ligator barrel.Device is now ready for ligation of haemorrhoids.¿ the instruction for use, ifu0030- 7, instructs the user in step 2.¿remove obturator from anoscope and inspect lumen.Up to three internal haemorrhoids will be aligned in the three slots of anoscope.Slots are designed to coincide with anatomical location of haemorrhoids in most adults.It may be necessary to rotate anoscope a small amount in either direction to encourage any swollen haemorrhoids to into place.Note: this anoscope may be used in patients with fewer than three haemorrhoids.¿ there is sufficient evidence to suggest that the user did not follow the ifu.Root cause (possible): 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 as the device was not returned.A possible root cause could be attributed to user not rotate the anoscope to align with the hemorrhoids.According to additional information received, no banding of the hemorrhoids was attempted and no suction of the haemorrhoids was attempted.As the user did not experience any difficulties gaining access to the banding site, a possible root cause is attribute to the manoeuvring of the anoscope to into position to align the haemorrhoids prior to banding.Summary: 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.This report is being submitted as a cancellation report.Additional information revealed no serious injury occurred and on clinical review user error was determined.The events do not meet the criteria of an fda mdr report.

• 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
• MDR Report Key: 8615532
• MDR Text Key: 145234715
• Report Number: 3001845648-2019-00212
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• PMA/PMN Number: K060623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 04/23/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1