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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA, INC DISPOSABLE ELECTROSURGICAL SNARE
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OLYMPUS AMERICA, INC DISPOSABLE ELECTROSURGICAL SNARE Back to Search Results
Model Number SD-210U-10
Health Effect - Clinical Code Laceration(s) (1946)
Date of Event 10/13/2022
Type of Reportable Event Serious Injury
Event or Problem Description
A user facility reported to olympus that while using the disposable electrosurgical snare, after snaring a large polyp, the physician could not cut or retract the snare.The snare and polyp both had to be surgically removed from the patient; the patient was taken to surgery immediately.Additional information has been requested; despite multiple attempts, none has been received.If received, a supplemental report will be sent.
 
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Brand Name
DISPOSABLE ELECTROSURGICAL SNARE
Common Device Name
DISPOSABLE ELECTROSURGICAL SNARE
Manufacturer (Section D)
OLYMPUS AMERICA, INC
3500 corporate parkway
center valley PA 18034 0610
MDR Report Key16158107
Report Number2429304-2023-00006
Device Sequence Number6958838
Product Code FDS
UDI-Device Identifier04953170298417
UDI-Public04953170298417
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/13/2023
Report Date (Section F) 12/19/2022
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? Yes
Operator of Device Health Professional
Device Model NumberSD-210U-10
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/19/2022
Event Location Hospital
Date Report to Manufacturer12/19/2022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/13/2023
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 Required Intervention;
Patient SexUnknown
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