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

Model Number SD-210U-25

Device Problem Off-Label Use (1494)

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

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 329485135
• Report Number: 9614641-2023-01818
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1