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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS Back to Search Results
Model Number FD-410LR
Device Problem Energy Output To Patient Tissue Incorrect (1209)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject device referenced in this report has not yet been 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

During an endoscopic submucosal dissection, the subject device was used. When the user activated the subject device to stop bleeding, but the subject device did not work. The intended procedure was completed with another device. There was no patient injury reported. This is the report regarding failure of output.

 
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Brand NameSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
Type of DeviceSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
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 
426425177
MDR Report Key7150240
MDR Text Key96129013
Report Number8010047-2017-02144
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK062517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFD-410LR
Device LOT Number77K
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/27/2017
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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