MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0545FCS

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported four (4) thunderbeat devices with the same model and lot number (tb-0545fcs, lot kr252813) failed during one procedure involving one patient.Thunderbeat device 1 and 2 devices were reported to have an unknown probe damage error when the surgeon was making light tissue contact.The thunderbeat device 3 and 4 did not work at all.The surgeon was able to successfully complete the procedure with a fifth thunderbeat device.There was a 30-45 minute procedural delay due to the device malfunctions.A request for additional information is in progress.This event includes the following 4 complaints: (b)(6) device 1 of 4 with unknown probe damage error.(b)(6) device 2 of 4 with unknown probe damage error.(b)(6) device 3 of 4, didn't work.(b)(6) device 4 of 4, didn't work.This report is 4 of 4 for (b)(6) device 4 of 4, didn't work.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the reported issue likely occurred due to a poor connection between td-tb400 and tb-0535fcs; and a poor connection between td-tb400 and usg-400.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿should any irregularity (error window, abnormal noise, abnormal output, abnormal operation, abnormal appearance, etc.) or malfunction be observed while using the thunderbeat, stop the use and withdraw the instruments from the body cavity.Do not withdraw the transducer plug from the ultrasonic generator.Check the equipment by referring to ¿troubleshooting¿, in the instruction manual for the ultrasonic generator.If the irregularity remains after troubleshooting, replace the transducer.If this does not resolve the issue, replace the thunderbeat instrument.If the irregularity remains unresolved, contact olympus.¿ ¿be sure to fully insert the transducer plug into the usg-400.Otherwise, an unsecure connection may result in unexpected disconnection of the transducer plug, resulting in no output which could lead to potential bleeding.¿ this supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15607963
• MDR Text Key: 304171569
• Report Number: 9614641-2022-00480
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383519
• UDI-Public: 04953170383519
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0545FCS
• Device Lot Number: KR252813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCOPE