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

Model Number FS-5Q-1

Device Problem Failure to Cut (2587)

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

Event Date 05/10/2023

Event Type  Injury  

Event Description

An olympus representative reported to olympus on behalf of the customer that when a pedunculated polyp was ligated with a single use ligating device and the excess thread was cut with the loop cutter, the thread got cut in the scissors and did not move.The doctor cut the hand part of the loop cutter, removed the endoscope, left the patient to wait for about an hour, reinserted the scope and used a new loop cutter to cut the ligature.The issue occurred during a colonoscopy.Details regarding the anesthesia used were unknown.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.The insertion portion was cut approximately 177 centimeters from the distal end.The loops were cut in the cutter storage part.There was no abnormality such as buckling in the insertion site.The handle section was not returned.The device history records were reviewed for the lots 25k through 34k* since the lot number of the device and date of delivery were unknown.The review revealed the lots had passed all the inspections relating to the reported incident.(*these lots were manufactured one year before the event date.) a definitive root cause could not be identified.However, based on the results of the device evaluation and the available information, the following likely occurred: 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.As a preventive measure, the instructions for use contain the following statements: ¿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.¿always have a spare instrument available.¿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.¿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.

• 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: 17100766
• MDR Text Key: 317032185
• Report Number: 9614641-2023-00829
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5Q-1
• Device Lot Number: K9Y07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention; Other