MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE X; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535FCX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During a laparoscopic partial hepatectomy, the subject device was used.The probe of the subject device was broken off into the patient.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the breakage of the subject device.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The probe was broken off at 12.5 mm from the distal end.There was scratch around the broken point.The broken probe tip was not returned.The fracture surface of the probe showed that crack developed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the probe was cracked when the user activated output contacting with metal or something hard object such as metal clips, stapler, or other instruments, besides the probe was broken off when the probe was subjected to a load.The above device handling has warned in the instruction manual as follows; do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE X
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9114762
• Report Number: 8010047-2019-03372
• Device Sequence Number: 2138858
• Product Code: GEI
• UDI-Device Identifier: 04953170392207
• UDI-Public: 04953170392207
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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-0535FCX
• Device Lot Number: 94K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1