MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LOOP CUTTER

Model Number FS-5U-1

Device Problem Difficult to Remove (1528)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation as the customer discarded the device.The device history records (dhr) were reviewed for the lots 26k through 35k since the lot number of the device and date of delivery were unknown.There were no issues detected in the dhr that are related to the reported phenomenon.The device was shipped in accordance with specifications.Based on the results of the investigation, the reported phenomenon and condition of the device could not be confirmed since the device was discarded by the user facility and will not be returned to olympus.The root cause of the event cannot be determined.However, an attempt was possibly made to cut the loop without the loop being on both sides of the loop hanger.This might have caused the loop to be caught in the cutter storage part.As a result, the loop could not be cut.The event can be detected/prevented by following the instructions for use, which state: before each case, prepare and inspect the instrument as instructed below.Inspect other equipment to be used with the instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument, contact olympus.Damage or irregularity may compromise patient or user safety, such as punctures, hemorrhages or mucous membrane damage and may result in more severe equipment damage.Be sure to perform the following preparations and inspections before use.Also, please check related devices used in combination with this product according to their "attachments or digitized attachments" and "instruction manuals".If any abnormality is suspected, do not use the endoscope, and contact the endoscope customer service center, our designated service center, or our branch or sales office.Using a loop cutter that is suspected to be abnormal may not only not function normally, but may also lead to perforation, major bleeding, mucous membrane damage, etc., as well as damage to the device or loss of functionality.Always have a spare instrument available.Prepare a spare loop cutter in case of unexpected failure.Do not try to cut the loop that is not positioned on both edges of the loop hanger as plumb as possible for the blade.It may make cutting the loop impossible or result in the loop getting caught in the distal end of the instrument, which could make it difficult or impossible to remove from the patient.In this case, use pliers to cut the insertion portion of the instrument where it extends from the biopsy valve of the endoscope.Remove the endoscope from the body, then reinsert the endoscope and cut the loop with a spare loop cutter.Place the loop on both sides of the loop holder so that it is as perpendicular to the cutter as possible and cut it.Depending on the angle at which the loop is sandwiched, not only can the loop not be cut, but the loop may get caught in the cutter section, preventing the loop cutter from being pulled out of the body.In the unlikely event that the loop cutter cannot be pulled out from the body, cut the insertion part of the loop cutter protruding from the endoscope forceps plug with pliers or the like, pull out the endoscope from the body, and re-enter the body.Insert the speculum and cut the loop with the spare loop cutter.Do not cut the loop unless you have a clear endoscopic field of view.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not cut the loop when the endoscope's field of view is not secured.It may lead to perforation, heavy bleeding, mucous membrane damage, etc., and may lead to damage to the endoscope or loop cutter.If it is difficult to cut two loops simultaneously, cut them one at a time.Forcible cutting may damage the loop cutter.If it is difficult to cut two loops at the same time, cut them one by one.Cutting with excessive force may damage the loop cutter.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that the scissors were caught in the loop cutter and could not be removed.It became impossible to do anything by digging between teeth when removing polyps.Correspond by cutting the hand part with nippers.The event occurred during a diagnostic endoscopy procedure.There was no delay, and the procedure was completed with a similar device.There was no patient harm associated with the event.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17295398
• MDR Text Key: 318764039
• Report Number: 9614641-2023-00964
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1