MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5MM 20CM FRONT-ACTUATED GRIP; THUNDERBEAT HANDPIECE

Model Number	TB-0520FC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
Event or Problem Description
The subject device was used during a nephrectomy.After short time use, the ptfe pad of the device was partially separated.The procedure was completed with a similar device.There was no patient harm reported.
Additional Manufacturer Narrative
This is a supplemental report for mfr report # 8010047-2016-01269 to provide additional information based on the evaluation of the device.Device manufacturer date was identified and filled in the report.The subject device was returned to olympus medical systems corp (omsc) for evaluation.As a result of evaluation of omsc on october 5, 2016, omsc confirmed that the ptfe pad of the device was partially peeled.The manufacturing record was reviewed with no irregularities.This type of ptfe pad damage is most likely related to the operator's technique.Based on the past similar cases, it was known that the ptfe pad was partially peeled when the user continued to activate seal & cut mode without contacting tissue (including after the tissue already cut).The instruction manual of the subject device already states; warnings: 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 ptfe pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.

• Brand Name: THUNDERBEAT 5MM 20CM FRONT-ACTUATED GRIP
• Common Device Name: THUNDERBEAT HANDPIECE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• MDR Report Key: 6002058
• Report Number: 8010047-2016-01269
• Device Sequence Number: 40457
• Product Code: GEI
• UDI-Device Identifier: 04953170370519
• UDI-Public: (01)04953170370519
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0520FC
• Device Lot Number: 65K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1