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

Model Number	FS-5L-1
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was disposed of, therefore, could not be evaluated by olympus.Due to the device being discarded, the allegation was not confirmed.Since the device lot number and the date of occurrence of the reported event were unknown, the following dhr of 1zk-2yk lot for past one year (from aware date to prior to the date of occurrence) was reviewed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The investigation concluded that the reported problem was likely due to cutting sutures with this product was outside the intended use.Therefore, it is likely that the reported phenomenon occurred because the user attempted to cut sutures that were not intended for use.However, a definitive root cause could not be determined.The instruction manual provides the following: 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.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 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 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.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.¿ olympus will continue to monitor field performance for this device.
Event or Problem Description
An olympus employee reported on behalf of a customer, the loop cutter when used to cut the thread after tissue suturing, the thread got caught in the jaw of the scissors at tip and jaw of scissors were cut.The jaws of scissors could no longer be opened or closed and as a result, the loop cutter got stuck in the patient¿s body.The scope became difficult to remove and another scope and treatment tool were used to release the stack.The procedure was completed using the subject device.The event occurred during a therapeutic duodenal endoscopic mucosal resection (emr).There was no report of patient harm associated with this procedure.The subject device was disposed of and could not be collected.

• Brand Name: LOOP CUTTER
• Common Device Name: 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: 16156035
• Report Number: 9614641-2023-00051
• Device Sequence Number: 20572602
• Product Code: FCL
• UDI-Device Identifier: 04953170033407
• UDI-Public: 04953170033407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FS-5L-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female