MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lapacolle surgery, an overcurrent error u010 occurred when using the subject device.The procedure and patient's anesthesia were extended by 30 minutes to deal with the errors as it occurred multiple times and to replace the transducer.The procedure was completed with the subject device.No additional medication was administered, and there were no reports of patient harm.
Additional Manufacturer Narrative
An olympus representative visited on site for inspection, and it was confirmed that the error code occurred with the generator alone.The generator was able to be used for around 30 minutes.Turning the power on and off 4 or 5 times or replacing the transducer did not improve the situation.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields (d4, d8, d9, h3, and h4).The device was evaluated by olympus, and it was observed the non-reportable malfunction (overcurrent error) was confirmed.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, it is likely the non-reportable malfunction (overcurrent error) was caused by a short circuit in the internal circuit board.It is possible that the short circuit resulted from dust accumulation inside the device; however, it was not possible to determine the exact circumstances of its occurrence.Furthermore, although the observed device defect (overcurrent error) is a non-reportable malfunction, the component failure likely caused and/or contributed to the reported adverse event (extended procedure).The event can be detected/prevented by following the instructions for use which state: "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 field performance for this device.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• 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: 20446565
• Report Number: 9614641-2024-01978
• Device Sequence Number: 8026180
• Product Code: LFL
• UDI-Device Identifier: 04953170386817
• UDI-Public: 04953170386817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: USG-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SB-0535FC/44K; TD-SB400
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown