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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection determined that the reported issue was not able to be duplicated.Unit was tested with a reference handpiece, the probe was found working, passed all functional and energy test with no issues observed.The device produced normal energy when the handpiece buttons were pressed and was tested for about 45 minutes with no issues observed.Based on evaluations findings reported issue was not confirmed as the device passed all required testing and specifications with no abnormalities or issues observed.
Event or Problem Description
It was reported that during an unspecified procedure the device was found not producing normal energy , interference saying electrical short message, no further information provided.No patient impact or harm reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Further communication with the customer conveyed the following information: sales representative came on customer site and the issue ended up being with the spl-t transducer and not the generator.The transducer was only a month old but failed and gave no output.The replacement unit worked properly on the generator.No further issue reported.Another complaint was opened to address the reported issue of the transducer.

• 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: 11246061
• Report Number: 3011050570-2021-00033
• Device Sequence Number: 3477386
• Product Code: FEO
• UDI-Device Identifier: 00855279005054
• UDI-Public: 0100855279005054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 01/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1