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

Model Number	SPL-T
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported transducer error code.Defective - error on the screen.The issue found during an unknown event.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
Device was retuned and evaluated.The complaint was confirmed.It was found that the unit failed to generate energy through a probe when s or h button pressed.No additional defects or failures were noted.Review of dhr's ( device history records) showed the product met all specifications upon release.Based on the investigation, the root cause of the reported issue could not be determined at this time.Possible situations related to the reported failures are addressed in the shockpulse lithotripsy ifu (instruction for use) on page 30 as the followings: 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." (spl-ifu_an, 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." (spl-ifu_an, page 30).The shockpulse lithotripsy ifu also states "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." (spl-ifu_an, page 3).Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 13447297
• Report Number: 3011050570-2022-00011
• Device Sequence Number: 17445754
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: 01/17/2022
• 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: 01/12/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2019
• 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