MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 10 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0510IC
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The evaluation did not duplicate the complaint for jaw misalignment.The jaw alignment was normal.Instead the evaluation found the teflon pad charred and pushed in on the side, exposing metal underneath the pad.A crack was also found on the probe, and the device failed the probe check.Based on similar reports, a potential cause for the damage to the teflon pad and to the probe is operator¿s technique.The device instruction manual contains several warning statements to prevent thermal and mechanical damage to the teflon pad and probe: ¿do not activate output while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.¿ ¿do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects¿.And ¿do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue or twisting the handle.¿ as a preventive measure in the event of device malfunction, the instruction manual also recommends that a spare device be available during the procedure.
Event or Problem Description
One (1) of 2.Olympus was informed that during an anal polyp excision procedure, the jaws of the device were misaligned, causing the device to not work after a few seconds.There was no reported patient injury or additional bleeding, and the patient was reported to be doing well.The procedure was completed with another similar device.

• Brand Name: THUNDERBEAT 5 MM, 10 CM, INLINE GRIP
• 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: 7887504
• Report Number: 2951238-2018-00548
• Device Sequence Number: 1940081
• Product Code: GEI
• UDI-Device Identifier: 04953170308734
• UDI-Public: 04953170308734
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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-0510IC
• Device Catalogue Number: TB-0510IC
• Device Lot Number: 85K30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1