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 resection of kidney tumor.The ptfe pad of the device was partially separated.There was no patient harm reported.No further information was reported.
Additional Manufacturer Narrative
This is a supplemental report for mfr report # 8010047-2016-01270 to provide additional information based on the evaluation of the device.The subject device was returned to olympus medical systems corp (omsc) for evaluation.Device manufacturer date was identified and filled in the report.The manufacturing record was reviewed with no irregularities.As a result of evaluation of omsc on october 5, 2016, there was no malfunction which caused or might cause the fragment to fall inside the patient.Therefore, we are retracting mdr.

• 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: 6002060
• Report Number: 8010047-2016-01270
• Device Sequence Number: 16162264
• 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,user facility
• Initial Reporter Occupation: Other
• 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