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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS THUNDERBEAT UNIT, ELECTROSURGICAL, ENDOSCOPIC

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OLYMPUS THUNDERBEAT UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
Catalog Number TB-0535FC
Device Problems Break (1069); Melted (1385); Electrical Shorting (2926)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2017
Event Type  malfunction  
Event Description
There have been three occurrences with the teflon pad on the thunderbeat. First occurrence. Thunderbeat (catalog# tb-0535fc/lot#mk644263) teflon pad melted and caused short circuit. No harm to patient. Second occurrence. Thunderbeat 35 cm (catalog# tb-0535fc/lot# mk644263) teflon came off early in the case. No harm to patient. Same lot# as first occurrence. Representative pulled the stock. Third occurrence. Thunderbeat (catalog# tb-0535fc/lot# mk662585) after one use, teflon pad looked damaged. No harm to patient. Representative pulled the stock from the inventory with the same lot# as was used in two of the events.
 
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Brand NameTHUNDERBEAT
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC
Manufacturer (Section D)
OLYMPUS
3500 corporate pkwy.
center valley PA 18034
MDR Report Key6837729
MDR Text Key84342005
Report Number6837729
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 Received09/01/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberTB-0535FC
Device Lot NumberMK662585,MK644263
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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