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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE HOT BIOPSY FORCEPS
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OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE HOT BIOPSY FORCEPS Back to Search Results
Model Number FD-210U
Device Problem Output Problem (3005)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/11/2019
Event Type  Injury  
Event Description
The service center was informed that the during the procedure two devices of the same lot did not work properly.The device contact was reported to be intermittent which caused a delay of treatment resulting in excessive bleeding.A clip was used to control the bleeding and complete the procedure.Additional information has been requested, but is not available at the time of this report.This report is for device 2 of 2.
 
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Brand Name
DISPOSABLE HOT BIOPSY FORCEPS
Type of Device
DISPOSABLE HOT BIOPSY FORCEPS
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key8884631
MDR Text Key154011363
Report Number2951238-2019-01055
Device Sequence Number1
Product Code KGE
UDI-Device Identifier04953170158759
UDI-Public04953170158759
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 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFD-210U
Device Lot Number8YV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/12/2019
Distributor Facility Aware Date07/17/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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