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

Model Number FS-5U-1

Device Problems Mechanical Problem (1384); Failure to Cut (2587)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

It was reported the doctor tried to cut the indwelling snare; however, it could not be cut and could not be opened or closed.It were stuck in the body, user was able to remove it by following the instructions in the instruction manual.The issue occurred during a therapeutic unspecified procedure.The intended procedure was completed with no harm or injury to the patient.No harm reported, no user injury reported due to the event.

Manufacturer Narrative

Initial reporter name and address: (b)(6).Subject device with model number fs-5u-1 was returned for evaluation.The lot no.Of subject device was k9y07.(date of manufacture: 7 november 2019).Device evaluation found the insertion portion was cut at the approximately 39cm from the distal end.The loop was stuck in the cutter storage.Operating the slider was smooth.No abnormalities such as buckling were observed in the insertion portion.The loops were able to be remove from the cutter, was moved using the tweezers.The length of the loops that were caught in the cutter storage part were about 2mm.There were no missing areas and nicks in the blade of the cutter.No abnormalities that could lead to the reported phenomenon were observed on the loop.An attempt was made to cut the returned loop by using fs-5u-1(olympus reference owned device).The loop was able to cut without any problems.The device history records (dhr¿s) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection sheet, quality inspection sheet, nonconforming product report.The instruction manual contains the following descriptions, and it warns against this event.(gw8636 rev.21) 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 being 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.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.If it is difficult to cut two loops simultaneously, cut them one at a time.Forcible cutting may damage the loop cutter.The root cause could not be conclusively determined.However, it is probable that 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.Olympus will continue to monitor complaints for this device.

• 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: 16551037
• MDR Text Key: 311699025
• Report Number: 9614641-2023-00382
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Device Lot Number: K9Y07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LOOP