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

Model Number	SPL-T
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation confirmed the user request as the power transducer could not be plugged into the generator due to a damaged power cord prong.Based on device inspection results, damage to transducer plug is most likely caused by improper handling.The instructions for use (ifu) states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.As a result of the device investigation, olympus has concluded that the damage to the device was likely caused by improper handling.This device is unrepairable, and thus was returned to the user facility as such.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
As reported, the power cord on the shockpulse lithotripsy transducer has a broken console connector.There was no reported patient harm or consequence from this event.
Additional Manufacturer Narrative
This supplemental report is to advise 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.

• 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: 11210626
• Report Number: 3011050570-2021-00024
• Device Sequence Number: 11584656
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: (01)00855279005023(11)170606
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1