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	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and the coating for electric insulation of the probe was partially missing around the scratch.The area around the scratch 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 and the coating for electric insulation of the probe was damaged 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.
Event or Problem Description
During a hepatobiliary and pancreatic procedure, the subject device was used.In procedure, the unspecified error occurred.The intended procedure was completed with another device.There was no patient injury reported.On (b)(6) 2019, olympus medical systems corp.(omsc) found that the probe was broken off and the coating for electric insulation of the probe was partially missing.This is the report regarding the breakage of the probe and the missing of the probe coating.

• 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: 8978563
• Report Number: 8010047-2019-03232
• Device Sequence Number: 11546429
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: No Information
• Device Model Number: TB-0535FCX
• Device Lot Number: 93K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1