MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
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
We received the following report.During a procedure of coelioscopy, the subject device was used.The distal end of the device broke off and fell inside the patient.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.
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 found to be broken off at 16mm from its tip.There were some scratches on the probe.The broken surface of the probe was checked.It indicated the probe had cracked from the scratch then broken off.There was a mark that hard object was caught in the tissue pad.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1)during output in seal & cut mode, the probe and the grasping section sandwiched with a hard object.2)this caused scratched the probe.3)the probe received an output load in seal & cut mode or received a load when grasping tissue.As a result, the probe cracked from the scratch.4)the probe broke when added load.The above device handling has warned in the instruction manual.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• 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: 10964039
• Report Number: 8010047-2020-09994
• Device Sequence Number: 19364931
• Product Code: GEI
• UDI-Device Identifier: 04953170409684
• UDI-Public: 04953170409684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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-0545FCS
• Device Lot Number: KR889406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1