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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X ULTRASONIC SURGICAL DEVICE

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OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X ULTRASONIC SURGICAL DEVICE Back to Search Results
Model Number TB-0520FCX
Device Problem Break
Event Date 06/10/2019
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The tissue pad of the subject device was severely worn and the proximal side of tissue pad was stuck out. The coating for electric insulation of the probe was partially missing. The manufacturing record was reviewed and found no irregularities. Based on the past similar cases, it was known that the coating for electric insulation of the probe and the tissue pad were damaged since the user continued to activate output without grasping tissue (including after the tissue already cut). The above device handling has warned in the instruction manual as follows: do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected. Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.

 
Event Description

During a procedure in pylorus side, the subject device was used. Open circuit error occurred. The tissue pad of the subject device was partially separated. The intended procedure was completed with another device. There was no patient injury reported. On jun 24, 2019, olympus medical systems corp. Found followings. The tissue pad of the subject device was severely worn. The proximal side of tissue pad was stuck out. The coating for electric insulation of the probe was partially missing. This is the report regarding the severely worn tissue pad, the protrusion of the tissue pad, and the missing of the probe coating.

 
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Brand NameTHUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X
Type of DeviceULTRASONIC SURGICAL DEVICE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to  192-8-507
  192-8507
426425177
MDR Report Key8746921
Report Number8010047-2019-02379
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 07/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTB-0520FCX
Device LOT Number91K
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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