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

Model Number SPL-T

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2020

Event Type  malfunction  

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 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.

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.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11252123
• MDR Text Key: 250463809
• Report Number: 3011050570-2021-00038
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: (01)00855279005023(11)180406
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1