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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION THUNDERBEAT UNIT, ELECTROSURGICAL, ENDOSCOPIC

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OLYMPUS MEDICAL SYSTEMS CORPORATION THUNDERBEAT UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
Catalog Number TB-0535FC
Device Problems Break (1069); Detachment Of Device Component (1104); Handpiece (3067); Tip (3123)
Patient Problem No Information (3190)
Event Date 10/13/2017
Event Type  Malfunction  
Event Description

While it was activated, a piece of metal broke off from the tip of the thunderbeat hand piece.

 
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Brand NameTHUNDERBEAT
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate pkwy.
center valley PA 18034
MDR Report Key6993085
MDR Text Key90792773
Report Number6993085
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017,10/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date07/28/2020
Device Catalogue NumberTB-0535FC
Device LOT NumberMK664851
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/19/2017
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer10/19/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/01/2017 Patient Sequence Number: 1
Treatment
NO
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