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

Model Number	SPL-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was inspected at rrc (regional repair center) olympus (b)(4).The complaint was confirmed.It was found that the suction port was broken off and there was wear and tear damage on the housing.Device history records were reviewed and showed the product met all specifications upon release.Based on the device inspection results, damage to the suction port was most likely due to user mishandling.The shockpulse lithotripsy ifu (instruction for use) (rev an) states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." (page 1); and "damage (mechanical and electrical) may result if the unit is dropped or struck against another object." (page 3) olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that "the device blew off the tip during the ongoing surgical application.Tip for suction device intraoperatively broken off." there was no patient injury or infection reported.No user injury was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response and updates.
Event or Problem Description
Updates on event reported per customer response: the procedure performed at the time of the event was a pnl (percutaneous litholapaxy).The intended procedure was successfully completed with a second identical 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: 13387746
• Report Number: 3011050570-2022-00009
• Device Sequence Number: 16579033
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 01/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2018
• 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