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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE
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OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE Back to Search Results
Model Number SD-240U-25
Health Effect - Clinical Code Bowel Perforation (2668)
Date of Event 07/10/2019
Type of Reportable Event Serious Injury
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.
 
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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 Key8917762
Report Number2951238-2019-01060
Device Sequence Number19290023
Product Code FDI
UDI-Device Identifier04953170165986
UDI-Public04953170165986
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/21/2019
Report Date (Section F) 08/21/2019
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 NumberSD-240U-25
Device Lot Number6XV
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/22/2019
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer07/22/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Date Report Sent to FDA08/21/2019
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