MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT TRANSDUCER

Model Number TD-TB400

Device Problem Defective Component (2292)

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

Event Date 12/16/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the probe of the thunderbeat transducer was not working.The issue was found during a therapeutic procedure.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated.The customer allegation was not confirmed.A cut was noted on the cord and minor scratches were noted on the housing.The technician noted that the issue may be an intermittent problem due to the cut on the cord.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The subject device was returned and tested, and the reported failure could not be reproduced.The following information is included in the instructions for use (ifu): ¿always inspect the ultrasonic generator as described in this chapter before using.Also, inspect the ancillary instrument used in combination with the ultrasonic generator according to the instruction manuals.Should any irregularity be observed, do not use the ultrasonic generator and take proper measures by referring to chapter 8, ¿troubleshooting¿.If the irregularity is still not resolved, do not use the ultrasonic generator and contact olympus.Using irregular instrument may cause a malfunction and may also result in an electric shock, burns and/or fire hazard.¿ ¿anytime you observe an irregularity (error window, abnormal noise, abnormal odor, abnormal output, abnormal appearance, etc.), immediately stop using the instrument and check/inspect the ultrasonic generator by referring to chapter 8, ¿troubleshooting¿.If the irregularity is still not resolved after the check/inspection, use a spare ultrasonic generator and/or contact olympus.¿ olympus will continue to monitor the performance of this device.

• Brand Name: THUNDERBEAT TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16184087
• MDR Text Key: 308362863
• Report Number: 9614641-2023-00068
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170306778
• UDI-Public: 04953170306778
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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
• Device Operator: Health Professional
• Device Model Number: TD-TB400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1