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

Model Number	USG-400
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported with an issue of "falling apart".No harm was reported.No patient harm, no user injury reported.
Additional Manufacturer Narrative
Follow up communication to the customer was made to gather additional information regarding the reported event.However, to date no response has been received.In addition, the subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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, there was cosmetic wear and tear.However, the definitive root cause of the device falling apart could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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: 16475689
• Report Number: 9614641-2023-00300
• Device Sequence Number: 3126161
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2013
• 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
• Patient Sex: Unknown