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 Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in this complaint has just recently been returned for evaluation.This evaluation and investigation is still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

After placement of the last band, the device would not detach from the rectum.The device detached after suction was removed.The clear plastic tip remained in-situ and had to be removed with snare.

Manufacturer Narrative

The customer reported the following complaint issue "after placement of the last band, the device would not detach from the rectum.The device detached after suction was removed.The clear plastic tip remained in-situ and had to be removed with snare.The patient did not require any additional procedure due to this occurrence.No adverse effect was reported due to this occurrence.¿ additional information was gathered: ¿can you confirm if there was a delay in the procedure as a result of the tip been removed? yes.The procedure was delayed as the tip needed to be retrieved.How was the snare used to remove the device, did they break the device to remove the tip? from what i understand a jumbo snare was looped over the tip in situ and tightened.They were then able to pull the tip off the mucosa.The tip and snare were not broken.Would this occurrence have led to harm of the patient? not in this case, as the tip was successfully removed.¿ the hmbl-4-tri device of lot c1275838 involved in this complaint was returned to (b)(4) and a lab evaluation was held on 16 jan 2017.During the lab evaluation it was noted that the tip was detached from the device, the tip was easily clipped/snapped back on.The device was opened up during the lab evaluation to check that the suction port/ valve was not blocked/ was working correctly.The suction port/valve was confirmed to be free from blockage or obstruction; a wire was passed through to verify the absence of blockage and photographed.This suction port is used to maintain or release suction during use; the customer covers the port with their finger to maintain suction and uncovers the port to reduce suction and release the tissue from the tip of the device.It was noted that the device functioned as expected during the lab evaluation and was free from defects that may have contributed to this occurrence.It was also noted that, given the event description where the customer states that "the device detached after suction was removed", the most probable root cause of this complaint would be attributed to user error as the customer most likely did not release suction at the suction port/valve.However this cannot be conclusively determined as the exact conditions of use could not be replicated in the laboratory setting.The complaint was confirmed based on customer testimony.According to the complaint description "the device would not detach from the rectum.The device detached after suction was removed".It should be noted that the device is designed to remain attached to the haemorrhoid until the suction has been removed.As stated in the instructions for use (ifu), the user is instructed to "uncover suction port of ligator to relieve suction on haemorrhoid.This will allow ligated haemorrhoid to be released from tip of device" it is likely that trying to remove the device while suction remained on may have contributed to the plastic tip detaching from the device; however as the exact conditions of use are unknown, this cannot be conclusively determined.The root cause of this complaint could not be conclusively determined.Prior to distribution, all hmbl devices are subjected to visual inspection and functional checks to ensure device integrity.The shortshot saeed hemorrhoidal multiband ligator with triview anoscope is used to ligate hemorrhoids facilitated by an anoscope.As per the notes section of the ifu ¿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.¿ a review of the manufacturing records for the hmbl device involved in this complaint ((b)(4)) did not reveal any discrepancies that could have contributed to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1275838; upon review of complaints this failure mode has not occurred previously with this lot # c1275838.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial description submitted as follows: after placement of the last band, the device would not detach from the rectum.The device detached after suction was removed.The clear plastic tip remained in-situ and had to be removed with snare.

• 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 Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6192541
• MDR Text Key: 62912818
• Report Number: 3001845648-2016-00380
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00827002340633
• UDI-Public: (01)00827002340633(17)170921(10)C1275838
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HMBL-4-TRI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2016
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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
• Patient Outcome(s): Required Intervention