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

Model Number	SPL-T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation confirmed the user report, as the transducer plug was damaged with the black end cover detached.The review of the device history record no abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage," and "take special care to ensure all cables are undamaged." olympus personnel have concluded the observed failure was most likely caused by user mishandling.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
As reported, the section of the shockpulse lithotripsy transducer that attaches to the monitor was noted to be broken during device maintenance.There was not reported patient involvement from this event.
Additional Manufacturer Narrative
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: 11252123
• Report Number: 3011050570-2021-00038
• Device Sequence Number: 3583580
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: (01)00855279005023(11)180406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• 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: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/29/2021
• 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