MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-240U-25
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device will not be returned to olympus for evaluation, due to it being disposed of.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
An olympus employee reported on behalf of a customer, during an unspecified procedure, the disposable electrosurgical snare could not cut through a large polyp (25 millimeter).Also, the snare loop could not be removed from the target tissue.The handle was cut off snare and the doctor was able to push the scope forward to release snare and remove scope.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was manufactured in november 2022.However, the specific date was unable to be determined.Additional information about the event was requested, but not received.If additional information becomes available, an additional supplemental report will be submitted.Based on the results of the investigation, and because the device was discarded, the definitive root cause of the electrosurgical snare issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿before use, prepare and inspect the instrument and a-cord as instructed below.Inspect other equipment used with the instrument and a-cord as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument or a-cord; contact olympus.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, punctures, hemorrhages, mucous membrane damage or thermal injury and may result in more severe equipment damage.During the procedure, if you determine that the instrument is not operating properly - due to breakage, disconnection of the operating pipe and operating wire, or burns to tissue from the snare loop - immediately stop using it, and carefully remove it to avoid patient injury.Using an instrument that is damaged and/or not operating properly could cause patient injury, such as hemorrhages, punctures or mucous membrane damage.In addition, the snare loop may burn and become stuck in the tissue, unable to be removed.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• 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: 17712703
• Report Number: 9614641-2023-01298
• Device Sequence Number: 6982270
• Product Code: FDI
• UDI-Device Identifier: 04953170165986
• UDI-Public: 04953170165986
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K955650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: SD-240U-25
• Device Lot Number: 2YV
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown