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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL SNARE SD-400

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL SNARE SD-400 Back to Search Results
Model Number SD-400U-10
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
We received the following report. The user noticed that there was a blue thread in the sterilization pack when the user checked it during preparation for use. The user removed it and used it as it was. There was no patient injury reported.
 
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Brand NameSINGLE USE ELECTROSURGICAL SNARE SD-400
Type of DeviceELECTROSURGICAL SNARE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key11070750
MDR Text Key223630180
Report Number8010047-2020-10951
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSD-400U-10
Device Lot Number01K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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