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

Model Number FS-5U-1

Device Problem Entrapment of Device (1212)

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

Event Date 09/08/2023

Event Type  Injury  

Event Description

The customer reported during a therapeutic gastroscopy procedure for a female, twenty-three year old patient they tried to cut the suture from the probe with single use loop cutter fs-410.The loop cutter did not cut the suture so the customer tried to cut it with fs-5u-1 loop cutter.The reusable version model, fs-5u-1, became stuck while cutting and the customer was unable to release the jaws of the loop cutter.They cut the handle and retrieved the scope from the patient.The patient was transferred to another hospital with the loop cutter still hanging out of the patients mouth.A second endoscopic examination was performed and with light pulling force the clip with the suture thread was able to be removed.The customer later confirmed there was no additional harm to the patient and the current status of the patient is good.A feeding probe was placed to ensure the patient receives sufficient intake.The jejunal extension was clipped to the mucosa with a suture and the suture became stuck in the fs-5u-1 loop cutter.The loop cutter with suture and extension have been removed.This event is reported under the following related patient identifiers: (b)(6) represents single use loop cutter fs-410.(b)(6) represents loop cutter fs-5u-1.This medwatch report is for patient identifier (b)(6) that represents loop cutter fs-5u-1.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and investigation results of the similar complaint in the past, it is likely an attempt was made to cut the suture without the suture being on both sides of the loop hanger.This might have caused the suture to be caught in the cutter storage part.As a result, the cutter could not be opened.However, the root cause of the suggested event could not be identified.The event can be prevented by following the instructions for use which state: 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 use the instrument to cut any objects other than the surplus of olympus loop (e.G., maj-254, maj-340).If anything other than the surplus of the loop is cut, the blades may be damaged and unable to perform properly, the cut object may be caught in the tip of the instrument, and it may become difficult to safety remove the instrument from the body.Such objects other than the surplus of loop may include, stent wire, sewing threads, and loop stoppers.Do not use the loop cutter to cut anything other than the loop.If you cut any other object, it may get caught in the distal end.This could make it difficult or impossible to remove it from the patient.If it is difficult to cut two loops simultaneously, cut them one at a time.Forcible cutting may damage the loop cutter.The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual, therefore, does not explain or discuss clinical endoscopic procedures.Olympus will continue to monitor field performance 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17856549
• MDR Text Key: 324769738
• Report Number: 9614641-2023-01446
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: SINGLE USE LOOP CUTTER FS-410
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female