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

Model Number SD-400U-10

Device Problem Failure to Cut (2587)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Perforation (2001); Gastrointestinal Hemorrhage (4476)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

This device has not been returned for evaluation.It was reported to have been destroyed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The user facility reported to olympus that during polypectomy using this electrosurgical system generator and single use electrosurgical snare sd-400, the user cannot cut, even stepped twice with 20w.The excision was performed with a pulse cut of 30w however, bleeding occurred.The customer attempted to stop the bleeding using a non-olympus device at 50w but failed even after increasing the power to 60w.After that, the power was increased to 67w and burnt off, and the bleeding was stopped with a clip to complete the procedure.After an overnight stay, the patient was discharged.The patient complained of abdominal pain and was readmitted.Hemostasis was performed again with a non-olympus device.The following day, the patient developed symptoms of diarrhea.When inspected, as reported to olympus, perforation had occurred due to baking.An operation has been planned.There were no reports of further patient or user harm associated with this event.Case with patient identifier (b)(6) reports the single use electrosurgical snare sd-400 used in the procedure.Case with patient identifier (b)(6) reports the electrosurgical system generator used in the procedure.

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, since the subject device was discarded and not returned for an evaluation, the root cause of the incident could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not use excessive force when snaring tissue.This could cause patient injury, such as hemorrhages or mucous membrane damage.¿ ¿do not snare tissue with excessive force.This could break the snare loop, which could cause patient injury such as punctures, hemorrhages, or thermal injury to non-target tissue from mechanical resection.¿ ¿always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as punctures, hemorrhages, or mucous membrane damage.¿ ¿when applying the current, do not use an excessive amount of conduction.Doing so could cause patient injuries such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed and confirm that no abnormalities are found in the patient.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Type of Device: 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: 16401468
• MDR Text Key: 309902057
• Report Number: 9614641-2023-00244
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170408243
• UDI-Public: 04953170408243
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-400U-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• 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
• Treatment: WB991046 SERIAL NUMBER (B)(4).
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: Asian