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

Model Number	SD-240U-25
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the snare was stuck and twisted on a polyp, while using the endotherapy.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide a correction to the initial with information inadvertently left out (b1, b2, e2, e3, g2,h1, h6) and to provide an update with information received (b5).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, since the snare loop was removed with the biopsy forceps, it is inferred that the snare loop was burned into the target tissue and could not be removed.However, information regarding occurrence situation was not provided from the customer.Furthermore, the subject device was not returned, and the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "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.
Event or Problem Description
It was reported that the customer was instructed to cut the insertion portion of the snare where it extends from the endoscope¿s instrument channel port.Then, remove the snare tube and move the snare wire back and forth to open the snare loop and remove it from the tissue.The customer was unable to remove this way.Instructed to remove scope, go back in with biopsy forceps and try to get snare off the polyp.It sounded like the customer was able to remove the snare from the polyp.

• 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: 19155944
• Report Number: 9614641-2024-00954
• Device Sequence Number: 15419204
• Product Code: FDI
• UDI-Device Identifier: 04953170298462
• UDI-Public: 04953170298462
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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-240U-25
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CF-HQ190L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown