MAUDE Adverse Event Report: GYRUS ACMI L.P. 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
Event or Problem Description
The customer reported that, during preparation for use, the suction connector on the subject device was found to be damaged.The device was sent to an olympus service center for evaluation.During inspection and testing, service found the tip of the suction port was broken and damaged.This report is being submitted for the malfunction found during evaluation (broken suction port).There was no effect on the patient due to the event.
Additional Manufacturer Narrative
During inspection and testing, service found the tip of the suction port was broken and damaged.A review of the device history record found no deviations that could have caused or contributed to the broken port.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the broken port was due to improper handling of the device.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following, which may help to prevent the issue: "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 field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15200081
• Report Number: 3005975494-2022-00026
• Device Sequence Number: 2111638
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 03/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2019
• 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