MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT OPEN EXTENDED JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0920OE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Burn, Thermal (2530)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.
Event or Problem Description
We received the following report.During a hemi colectomy, the subject device was used.In the procedure, unintended contact with the device caused burn and perforation.The perforation was recognized at the time and addressed accordingly.The intended procedure was completed with an unspecified intervention procedure.No further information was provided.The subject device was discarded by the user.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not sent back for investigation.Therefore, the phenomenon of the reported event could not be confirmed.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past six months from the event date, it was found no irregularities.The exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.No abnormalities were found in the manufacturing record.Therefore, the phenomenon which was pointed out could not be confirmed.There is a possibility the heated device touched the patients tissue after activation, causing the reported "the unintended burn and the perforation".The above device handling has warned in the instruction manual as follows.Use the thunderbeat instrument properly.Improper use may cause the probe tip to fall off inside the body cavity, premature wear, partial separating, deformation, breakage, patient and/or operator injury, malfunction of the cardiac pacemaker, burns of the surgeon, surgical staff and/or patient, electric shock, abnormal output or malfunction, perforation, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff and/or patient.Before activating the output, be sure that neither the grasping section nor the probe tip comes into contact with the surrounding tissue.Do not use the thunderbeat if you do not have a sufficient view to confirm the above or if the grasping section and probe tip are penetrating into the tissues.Otherwise, perforation, bleeding, or burns may result.Do not use the thunderbeat if you do not have a sufficient view of the grasping section and probe tip to ensure that only the intended tissue is in contact with the grasping section.

• Brand Name: THUNDERBEAT OPEN EXTENDED JAW
• 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: 10360458
• Report Number: 8010047-2020-05226
• Device Sequence Number: 14190919
• Product Code: GEI
• UDI-Device Identifier: 04953170343308
• UDI-Public: 04953170343308
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: TB-0920OE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention