MAUDE Adverse Event Report: CYBERSONICS, INC. SHOCKPULSE LITHOTRIPSY TRANSDUCER

Model Number SPL-T

Device Problem Activation Problem (4042)

Patient Problem No Code Available (3191)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The referenced spl-t was returned to the manufacturer for evaluation.A visual inspection was performed on the returned spl-t; there was normal cosmetic wear and tear observed from minor scratches.The spl-t was received with the nose cone and spl-w wrench.The spl-t was tested in conjunction with our test spl-g test generator unit and footswitch.The generator-transducer detect circuit check tested normal as the receptacle light ring goes from blinking to solid when the spl-t is plugged in.A standard and high power test was performed and confirmed the hand switch is unable to activate in standard power and high power as the check probe / error indicators light up red.There was no power to the spl-t during activation.The exact cause of the reported event could not be conclusively determined.The troubleshoot section of the instructions for use states potential causes of the check probe / error indicators light up red could be the transducer may have malfunctioned.To remediate, reboot the generator by turning power off / then back on and plug in a second transducer to the generator.As a preventive measure, the instructions for use (ifu) indicates a back-up transducer and probe should be sterilized and available prior to beginning a procedure.Perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance.Thoroughly inspect all electrical cables and probes before each use.Do not use if there is any evidence of deterioration.Replace if any damage or excessive wear is observed.Inspect the transducer plug pins, cord, and transducer body for mechanical damage (bent pins, cracks, etc.).After each use or prior to cleaning and sterilizing, carefully inspect the transducer and cable for tears, cracks, or other signs of damage.Do not use a shockpulse-se system that fails to meet the criteria stated in the labeling or that has been damaged.Otherwise, injury to the patient, personnel and / or an adverse effect on the procedure could result.In addition, the transducer has a typical product life of 100 uses, however, if the performance of the transducer is adequate it may continue to be used.

Event Description

The manufacturer was informed that during a percutaneous nephrolithotomy (pcnl) procedure, the doctor was using the transducer (spl-t) when the generator indicated a check probe error and an error on the system.The probe attached to the transducer was replaced and other troubleshooting methods were tried but the device had the same issue.The intended procedure was cancelled and the patient will require a second procedure with general anesthesia to remove the remaining stones.There was no patient injury and the patient did not require a longer stay.However, patient bleeding was reported due to invasive gaining access.The doctor determined the issue was from the transducer as the doctor switched to a second transducer and it worked appropriately.Additionally, the user facility reported the transducer was not inspected/tested prior to use.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for the concerned device.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There were no associated ncrs, scrap or recorded process deviations documented relating to the reported failure.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER
• Type of Device: LITHOTRIPSY TRANSDUCER
• Manufacturer (Section D): CYBERSONICS, INC.; knowledge park; erie PA 16510
• MDR Report Key: 8873980
• MDR Text Key: 155168151
• Report Number: 2951238-2019-01051
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR: MAKE/MODEL/SERIAL UNKNOWN; PROBE: MAKE/MODEL/SERIAL OR LOT UNKNOWN