MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device serial number (b)(4) was returned to olympus for evaluation.The unit was inspected and tested.All functions and outputs are in standard specification.The unit passed the functional test, output test and electrical safety test.Minor scratches on the housing were observed.The label was cleaned.The device is a legacy model, once the functional test and electrical test were completed the device was placed in the return in stock and is not returned to the customer.As a preventive measure, the instruction manual states: the ultrasonic generator does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it.Patient or user injury and/or equipment damage can result.If an irregularity appears to be minor, refer to chapter 8, ¿troubleshooting¿.If the irregularity cannot be resolved, do not use the ultrasonic generator and contact olympus.
Event or Problem Description
It was reported that during a therapeutic procedure an error message of ¿short circuit error¿ occurred.The device according to the user was inspected prior to use and no abnormalities were observed.The intended procedure was completed using another similar device.There was no patient injury or harm reported due to the event.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9884914
• Report Number: 8010047-2020-01870
• Device Sequence Number: 2320553
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1