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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-210U-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 10/25/2017
Event Type  Injury  
Manufacturer Narrative
This supplemental report is submitted to correct "device product code. ".
 
Manufacturer Narrative
The subject device has not been returned to olympus medical system corp. (omsc) for investigation since it was discarded by user facility. The exact cause of the reported phenomenon could not be conclusively determined. The device history record for the lot indicated no abnormality with the event-related items. Based on the past similar cases, omsc assumed that the bleeding occurred due to the state of the tissue, but the cause of the event could not be identified. The instruction manual of the device has already warned as follows; when applying the current, do not use an excessive amount of conduction. Doing so could cause patient injury such as perforations and/or bleeding. When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure. Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.
 
Event Description
During an unspecified procedure, the subject device was used. There was a bleeding from the treatment area with the subject device. The physician performed clipping several times, but could not stop bleeding easily. There was no further patient injury reported.
 
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Brand NameDISPOSABLE ELECTROSURGICAL SNARE
Type of DeviceDISPOSABLE ELECTROSURGICAL SNARE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7073282
MDR Text Key249642046
Report Number8010047-2017-01879
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK984358
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 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSD-210U-25
Device Lot Number71K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/30/2017 Patient Sequence Number: 1
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