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

Model Number	SPL-T
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.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.
Event or Problem Description
It was reported the device was not working, the error light on the device was highlighted.The issue was found during a percutaneous nephrectomy procedure (therapeutic).The device was replaced and the intended procedure was completed using a similar device.There was a delay of approximately twenty (20) minutes in the procedure, however, per the report, there was no patient harm or adverse event occurred due to the delay.No harm was reported, no patient injury, no user injury as a result of the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Correction: the initial medwatch incorrectly reported the site registration number.The site registration number is (b)(4).The device was returned and an evaluation was completed for it.During inspection, olympus confirmed the reported event, the generator error light was illuminated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely error light on the generator being illuminated occurred due to the device being used beyond its expected product lifespan.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿olympus recommends that the generator and transducer are returned every 24 months for a calibration and safety inspection.(page 29) perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance.(page 3) it is always recommended that a spare transducer and probe assembly be available.(page 20).¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction: d3, g1, h11.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16729792
• Report Number: 3005975494-2023-00067
• Device Sequence Number: 6663514
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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: 04/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 06/17/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/19/2023; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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