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

Model Number	SD-210U-10
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that while using the disposable electrosurgical snare, after snaring a large polyp, the physician could not cut or retract the snare.The snare and polyp both had to be surgically removed from the patient; the patient was taken to surgery immediately.Additional information has been requested; despite multiple attempts, none has been received.If received, a supplemental report will be sent.
Additional Manufacturer Narrative
The device was not returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report was submitted on importer's report number 2429304 - 2023 - 00006.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the snare was not receiving a current.This may have prevented the snare from cutting a polyp and retracting into the tube.It is likely that the snare was not receiving a current because the connection between the plug and a cord, or a cord and the electrosurgical unit was insufficient, or the target area likely contained high moisture content.(e.G., mucus, blood) therefore, the high frequency current density has decreased.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.If the snare loop cannot be removed from the tissue, follow the instructions given below.¿ 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: 16158857
• Report Number: 9614641-2023-00053
• Device Sequence Number: 7507495
• Product Code: FDS
• UDI-Device Identifier: 04953170298417
• UDI-Public: 04953170298417
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K902735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD-210U-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown