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

Model Number G34063

Device Problems Biocompatibility (2886); Activation, Positioning or Separation Problem (2906)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User sucked the target mucosa three times and released the band, but the band slip off immediately.User then changed to another same device to complete the procedure.Patient outcome: "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.".

Event Description

Lab evaluation completed on 26-jul-21, no defect observed.Banks seemd to shrink as expected when deployed in lab.User sucked the target mucosa three times and released the band, but the band slip off immediately.User then changed to another same device to complete the procedure.Patient outcome: "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.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: the hmbl-4-tri device of lot number c1794363 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.From the images provided, one band appears undeployed on device and three other bands are deployed.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 26th july 2021.In summary the following results were observed in the lab evaluation: one band returned undeployed on device.This band was deployed in the lab and shrunk as expected.Three other bands were returned already deployed and had also shrunk as expected.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 cirl.A review of the manufacturing records for the hmbl-4-tri devices of lot # c1794363 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot #c1794363 ; upon review of complaints this failure mode has not occurred previously with this lot #c1794363.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 ¿ maintain suction of haemorrhoid by keeping suction port covered.Deploy band by slowly rotating suction spool downwards until tension is released.¿ ¿uncover suction port of ligator to relieve suction on haemorrhoid.This will allow ligated haemorrhoid toe be released from tip of device.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the users technique during the procedure.It is possible that 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.It may be noted that the bands seemed to shrink as expected when deployed during the laboratory evaluation.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, 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.

• 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: 11981275
• MDR Text Key: 255617373
• Report Number: 3001845648-2021-00462
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)220125(10)C1794363
• 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,Followup
• Report Date: 09/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: G34063
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: C1794363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 05/14/2021; 05/14/2021
• Supplement Dates FDA Received: 08/24/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR