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

Model Number	USG-400
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes attributed to adverse event: other serious (important medical events): blood loss, amount unknown.(b)(4).In speaking with olympus technical access center (tac) via the phone, the customer reported the subject device displayed an incorrect connection message.Troubleshooting advise was provided via phone by tac.The customer was advised that the lower connector needed to be fully connected to ensure an adequate connection.The devices referenced in this report were not returned to olympus for service as the issue resolved with providing the customer with troubleshooting advice over the phone.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.This report has been reported by the importer on mdr# 2951238-2021-00418.
Event or Problem Description
The customer reported to olympus the ultrasonic generator displayed an incorrect connection message during an unknown procedure.The customer stated the patient was bleeding while on the exam table.The amount of blood loss the patient sustained is unknown.The procedure was completed using a similar device in another procedure room.The patient did not experience further blood loss and recovered.No additional patient information was provided by the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to a connection/locking issue.As stated in the instructions for use: 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, 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.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12548507
• Report Number: 8010047-2021-12455
• Device Sequence Number: 18037735
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: USG-400
• Was Device Available for Evaluation?: No
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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: MAJ-1876 DOCKING FIXTURE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown