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

Model Number	SD-210U-25
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the customer and will not be returned to olympus for evaluation.Olympus noticed that the device is only a hot snare, and in the hospital system it was mentioned that it is a cold/hot snare.Olympus has contacted hospital to advise about the use of this device and it has been requested that the hospital changes their system so that the description of the product is marked as only a hot option.The investigation is ongoing.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
The customer reported to olympus that the disposable electrosurgical snare cold snare option does not work and they had to change to hot snare during procedure and they noticed the package does not mention cold snare at all.The procedure was finished with the hot option.There were no reports of patient or user harm associated.
Additional Manufacturer Narrative
Correction to h6 type of investigation: the device was discarded and code "10 - testing of actual/suspected device" was inadvertently added.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was manufactured in march 2023, but the specific date is unknown.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, the event occurred because the user mistakenly recognized the subject device had a function as a cold snare.The event can be prevented by following the instructions for use which state: ·"the disposable electrosurgical snare sd-210/221/230/240 series have been designed to be used with an olympus endoscope to electrosurgically resect tissue within the digestive tract.·make sure that electricity is supplied to the instrument when making an incision.Incision without electricity may result in hemorrhages or mucous membrane damage." 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: 18246462
• Report Number: 9614641-2023-01818
• Device Sequence Number: 12407709
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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-210U-25
• Device Lot Number: 33V
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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