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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC

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OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
Model Number TB-0535FC
Device Problems Peeled/Delaminated (1454); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2018
Event Type  Malfunction  
Event Description

Thunderbeat 5mm, 35cm, front actuated grip ref #tb-0535fc olympus tip of grip peeled off. Hand piece taken off surgical field and peeling grip still in place. A new thunderbeat opened and broken one taken off field and turned in to materials management and charge nurse notified, broken handpiece taken off surgical field and replaced with a new thunderbeat handle. Contacted manufacturer and rma has been assigned to replacement of device. Olympus will need to send in box for viable return of product for investigation.

 
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Brand NameTHUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate pkwy.
center valley PA 18034
MDR Report Key7439515
MDR Text Key105797712
Report Number7439515
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 03/06/2018,04/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberTB-0535FC
Device Catalogue NumberTB-0535FC
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2018
Event Location Hospital
Date Report TO Manufacturer03/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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