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

Model Number SD-230U-20

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation without the original packaging.During inspection and testing, the allegation was confirmed.A visual inspection found foreign substance adhered to the loop tip and debris on the loop wires.There was a charring substance and biomaterial stains inside the distal tube sheath as signs of use.However, no physical damage was found on the tube sheath, and the handle slider was functioning properly.The device passed the continuity check between the loop and plug contact pin.Based on the evaluation findings, the reported complaint was confirmed; however, the device had signs of being used instead of an out of box failure.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, tissue found on snare out the box of a disposable electrosurgical snare.The event occurred during preparation for use.The doctor noticed foreign substance on the snare before passing it down the scope and as a result did not use the device on a patient.A new device was opened with no issues.There was no reported patient harm associated with this event.

Event Description

Additional information was provided regarding this event.The intended procedure was an unspecified therapeutic procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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, the definitive root cause of the foreign material could not be determined.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 (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: 16153612
• MDR Text Key: 308726923
• Report Number: 9614641-2023-00049
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170328190
• UDI-Public: 04953170328190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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: V2823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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