MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-T
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus while preparing for use, a transducer error code and other error messages displayed when the shockpulse lithotripsy transducer was plugged in.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
The device has not been received to date.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for evaluation, a root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿regarding check probe illumination, possible causes may be ¿the probe is loose¿ or ¿the probe has failed or has a crack.¿ troubleshooting this problem includes ¿remove the probe and clean the mating surfaces of the probe and transducer.Reattach probe using the wrench,¿ or ¿replace probe.¿ " ¿for the problem with error indicator illumination, ¿the transducer may have malfunctioned.¿ troubleshooting this problem includes ¿reboot generator by turning power off and then back on.Plug in a second transducer to the generator.¿ in addition, the ifu advises ¿it is always recommended that a spare transducer and probe assembly be available.¿ ¿ olympus will continue to monitor field performance for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15709725
• Report Number: 3011050570-2022-00120
• Device Sequence Number: 5144895
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: SPL-T
• Was Device Available for Evaluation?: No
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown