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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 Probe (918); Break (1069); Detachment Of Device Component (1104); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2017
Event Type  Malfunction  
Event Description

The probe tip broke off while in use and was recovered. There was no harm to the patient. Vendor representative present at time of event. The event was discussed with the surgeon.

 
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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 Key6841567
MDR Text Key84643291
Report Number6841567
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 08/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberTB-0535FC
Device LOT NumberMK662591
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/16/2017
Event Location Hospital
Date Report TO Manufacturer08/16/2017
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

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