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

Model Number	SD-210U-25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an endoscopic retrograde cholangiopancreatography procedure 2 pieces of single use electrosurgical device broke off the loop.The procedure was able to be completed.The procedure was reportedly delayed for 1.5 to 2 hours.The device was inspected before use and no fault was reported.Additional follow-up for patient outcome and procedural details was conducted but no information could be received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out field (b5) and to provide an update to fields (h3 and h4).The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported event.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 no abnormalities leading to the reported event were found in the subject device, the root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "these instruments have been designed to be used with an olympus endoscope to electrosurgically resect tissue within the digestive tract.Do not use these instruments for any purpose other than their intended uses." "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." "do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion." "never use excessive force to extend or retract the snare loop.This could damage the instrument." "if tissue is snared with excessive force, the snare loop or the tube may become deformed.If this occurs, do not use the instrument; use a spare instead." olympus will continue to monitor field performance for this device.
Event or Problem Description
Information inadvertently left out: it was reported that the noose did not remain in the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide correction with information inadvertently left out (b5 and d10).
Event or Problem Description
Information inadvertently left out: it was reported that the guidewire detached inside the duodenoscope and was found to be off when it was pulled out.Additionally, the foreign object was a hydra jagwire guidewire.

• 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: 19808539
• Report Number: 9614641-2024-01490
• Device Sequence Number: 15540756
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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-25
• Device Lot Number: V3620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 02/26/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 12/11/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2 DUODENOSCOPES, MODEL AND SN-UNKNOWN; BOSTON HYDRA JAGWIRE GUIDEWIRE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown