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

Model Number	SPL-T
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegations were confirmed.They were found to be caused by a faulty transducer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
An olympus rep reported on behalf of the customer, the shockpulse lithotripsy transducer displayed an error code.Both the error light and probe check light were lit.The event occurred in the middle of a therapeutic left complex percutaneous nephrolithotomy.The procedure was delayed while the user facility tried troubleshooting without success; and had to be completed using another device.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
D4 has been corrected.
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, the issue was likely due to a faulty transducer.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): - 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." (page 30) - 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." (page 30) in addition, the ifu advises "it is always recommended that a spare transducer and probe assembly be available." (page 20).Olympus will continue to monitor the field performance of 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: 15633929
• Report Number: 3005975494-2022-00052
• Device Sequence Number: 7975048
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 11/15/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/11/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• 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