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

Model Number FS-5U-1

Device Problem Mechanical Problem (1384)

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

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Customer full establishment name is (b)(6) hospital.The subject device was returned and evaluated.Device evaluation , the following were noted : the lot number was k0903.(m-bc manufacture date: sep 3, 2020).The loop which was cut was returned.Inspection noted , the loop was caught in the cutter storage part.Operating the slider did not open or close the cutter., no abnormalities such as buckling were observed in the insertion portion.The loop was able to remove the cutter was moved using the tweezers.When pushing and pulling the slider, the cutter opened and closed smoothly.There were no missing areas and nicks in the blade of the cutter.An attempt was made to cut the returned loop by using the subject device (fs-5u-1).The loop was able to cut without any problems.The dhrs (device history records) for this product have been reviewed.The dhr with the subject lot number confirmed.No abnormalities were detected in the dhr for the following 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 rev22).·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.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.

Event Description

As reported, when user grabbed the loop of the indwelling snare, it got tangled in the loop and could not cut temporarily and subsequently the loop was able to be cut.The intended unspecified procedure was completed.No health hazard to the patient was reported.Item has been collected.There was no patient harm, no user injury reported due to the event.

• Brand Name: LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki; 2-248-1 okkonoki, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15558524
• MDR Text Key: 306377233
• Report Number: 9614641-2022-00431
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS1-EXMPT
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: K0903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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