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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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OLYMPUS CORPORATION OF THE AMERICAS THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number TB-0535FC
Device Problems Break (1069); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/26/2018
Event Type  Malfunction  
Event Description

Tip of the thunderbeat device broke off during use for the laparoscopic surgery. All pieces were retrieved and saved. No patient harm.

 
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Brand NameTHUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
3500 corporate pkwy.
center valley PA 18034
MDR Report Key7761976
MDR Text Key116448687
Report Number7761976
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTB-0535FC
Device Catalogue NumberTB-0535FC
Device LOT NumberMK733680
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2018
Event Location Hospital
Date Report TO Manufacturer08/08/2018
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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