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

Model Number	SPL-T
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation, a review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The device was returned in inspected.During the inspection, the user report was confirmed as the suction nipple of the device was broken off.Additionally, minor scratches were noted on the housing.Device history records were reviewed and showed the product met all specifications upon release.Based on device inspection results, the damage found on the device was most likely due to user mishandling.The device ifu advises "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage," olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported, the shockpulse lithotripsy transducer was not recognized by the generator.According to the initial reporter, the device was broken on the end and was not functioning properly.There was no patient harm or consequence reported as a result of this event.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11701419
• Report Number: 3011050570-2021-00063
• Device Sequence Number: 3535698
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1