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

Model Number SD-230U-20

Device Problem Difficult to Remove (1528)

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

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a polypectomy procedure using a disposable electrosurgical snare, when the cautery was activated on spiral snare, the cautery did not work.Maj-860 cautery cable was being used with vio300.Second vio300 was brought into the room to trouble shoot.The cautery on disposable electrosurgical snare still did not activate, same maj-860 cautery cable was used.The snare could not be removed from large polyp, it was impacted.Eventually the physician was able to pull the snare through the polyp without cautery, but with extreme difficulty after 15+ minutes and increased patient discomfort.The snare was mangled, at the attachment between the sheath and handle.A second disposable electrosurgical snare was opened and used with the second vio300 and existing maj-860 and it performed as expected.The remaining polyp tissue was removed without further incident.The nurse at the bed side did mention the snare did not seem to function as normal after repeated attempts to remove the snare.The snare had been opened and closed repeatedly to determine if the tissue had released and if the machinery was potentially involved.At the first attempt to use cautery there was no indication that the snare was receiving a current, no smoke or burnt tissue or coagulated fluid noted.The physician attempted multiple different polypectomy settings on both erbes and no change in snare functionality.The second snare was tested on the mucosa prior to snaring the polyp tissue to ensure it was functioning and performed without issue.The customer confirmed there was no serious injury to the patient.The procedure was prolonged, the physician and nurse assisting spent significant time attempting to remove the impacted snare from the polyp.Eventually the snare had to be torn from a smaller portion of the polyp where it could not be released.The patient required additional sedation and analgesia to perform the procedure.The procedure was potentially more painful as a result of the increased time and maneuvering of the scope.The patient was discharged home in stable condition.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, likely factors causing the ¿snare not receiving a current¿ are as follows: 1.The connection between the plug and a cord, or a cord and the electrosurgical unit was insufficient.2.The target area might have contained high moisture content.(e.G., mucus, blood) therefore, the high frequency current density has decreased.Furthermore, likely factors causing the snare to be caught in the target tissue and unable to be removed are as follows: 1.The target tissue to be snared was too large.2.The target tissue to be snared was pedunculated.It is likely that a bending load was applied to the base of the operation part during handling, causing the device to break at the attachment between the sheath and handle.The event can be detected/prevented by following the instructions for use (ifu) 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.¿ ¿do not perform a current test on any substance that may adhere to the snare loop before use (e.G., soap).Substances that are stuck on the snare wire may inhibit the high-frequency current output, resulting in hemorrhages.¿ ¿if the snare loop cannot be removed from the tissue, follow the instructions given below.1.Move the snare tube back and forth or turn the angulation knob of the endoscope to open the snare loop and remove it from the tissue.2.If it is still difficult to remove the snare loop after performing step 1, use pliers 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.¿ 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15579292
• MDR Text Key: 307160320
• Report Number: 9614641-2022-00450
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170328190
• UDI-Public: 04953170328190
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD-230U-20
• Device Lot Number: 17V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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