MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number	SD-400U-10
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus representative reported on behalf of the customer that during the therapeutic procedure, the single-use electrosurgical snare did not cauterize when used with the erbe.The cable and the erbe were changed, and the problem remained.The procedure was delayed for 15 to 20 minutes while troubleshooting was performed and there was an extension of the patient's anesthesia.There was not a clinically relevant prolongation of the procedure.The procedure was completed with another device.Related patient identifier: (b)(6).(model: sd-400u-10.Sn: (b)(6)).
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured on june 2023 based on the provided 3-digit lot information.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 subject device could not be inspected.However, based on the results of investigation performed in the past, a likely factor causing the reported phenomenon might be the following: the connection between the plug and a cord, or a cord and the electrosurgical unit was insufficient.The target area might have contained high moisture content.(e.G.Mucus, blood) therefore, the high frequency current density has decreased.The following are 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.Prior to use, connect the patient plate, s-cord and p-cord or s-p cord as instructed in the electrosurgical unit¿s instruction manual".Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Common Device Name: 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: 17957717
• Report Number: 9614641-2023-01552
• Device Sequence Number: 17903440
• Product Code: FDI
• UDI-Device Identifier: 04953170408243
• UDI-Public: 04953170408243
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172734
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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-400U-10
• Device Lot Number: 36V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ERBE.
• Patient Sex: Unknown