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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bowel Perforation (2668)
Event Date 07/10/2019
Event Type  Injury  
Event 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
Type of Device
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
MDR Text Key155109641
Report Number2951238-2019-01060
Device Sequence Number1
Product Code FDI
UDI-Device Identifier04953170165986
UDI-Public04953170165986
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Model NumberSD-240U-25
Device Lot Number6XV
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2019
Distributor Facility Aware Date07/22/2019
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer07/22/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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