MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-S
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and evaluated.Device was received with footswitch accessory unit.The device was tested and all functional, energy output and leakage test were performed with no issues observed.Minor cosmetic issues were observed on the housing front panel however, the device functionality was not affected by the cosmetic issue observed.The device was placed in stock inventory.The root cause of the reported issue is unknown.The device passed all required functional testing with no issue observed.
Event or Problem Description
It was reported that during an unspecified procedure the device exhibited a check probe error message.The spl-s (shockpulse-se lithotripsy system) ran continually when the foot pedal was plugged in.The check probe indicator and the alarm indicator was showing red.The user was not able to use the high power option on the foot pedal.The user tried another probe spl-pd376 with the foot pedal plugged in and had the same results.The customer was then able to use the probe when the foot pedal was unplugged without error and was able to complete the procedure.There was no patient harm or injury reported due to the event.No user injury reported.
Event or Problem Description
Updated information on the event reported.The event occurred during a therapeutic pcnl(percutaneous nephrolithotomy ) procedure.No other devices were involved in the event or replaced during the course of the procedure.The procedure was delayed 5 minutes no information was provided as to whether or not the patient was under general anesthesia.The procedure was completed with the same device.No patient information was provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause of the reported phenomenon could not be determined.Per device ifu (instruction for use) : the check probe indicator is illuminated red when the probe is causing a malfunction.The probe should be checked for proper attachment to the transducer using the wrench.The probe should also be checked for any signs of failure such as tip wear or cracks.The probe is loose; solution: remove the probe and clean the mating surfaces of the probe and transducer.Reattach probe using the wrench and possible cause: the probe has failed or has a crack; solution: replace probe.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10824958
• Report Number: 3011050570-2020-00144
• Device Sequence Number: 16898049
• Product Code: FEO
• UDI-Device Identifier: 00855279005054
• UDI-Public: 0100855279005054
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2021

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-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 01/27/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/29/2020; 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOOTSWITCH.