MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-240U-25
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The cause of the reported event cannot be determined; however, this type of reported phenomenon is most likely related to the operator's technique.Indications for use: 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.The instructions for use contains the following warning: "pull the slider to confirm that the distal end of the snare loop is completely retracted into the snare tube.When using the instrument while the snare loop is not completely retracted into the snare tube, the strangulation becomes insufficient and the tissue may not be resected completely and hemorrhages, punctures, or mucous membrane damage could result.In addition, it may be impossible to remove the snare loop from tissue due to burn on tissue." the instructions for use also states to "always have pliers ready to cut the insertion portion in case the snare loop cannot be removed from snared tissue.".If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
It was reported by the user facility that during a polyp removal procedure using a sd-240u-25 disposable electrosurgical snare, the polyp could not be removed.The cautery unit and the snare were changed twice, without success.The patient was transferred to the hospital and underwent a colon resection with a ileostomy surgery to repair the perforation.The patient discharged two weeks later.No additional details are available at this time.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8906772
• Report Number: 8010047-2019-02952
• Device Sequence Number: 16743299
• Product Code: FDI
• UDI-Device Identifier: 04953170165986
• UDI-Public: 04953170165986
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K955650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: SD-240U-25
• Device Lot Number: 6XV
• 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: 07/22/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention