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

Model Number SPL-T

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device failed to work with a spl-s generator when the l and h buttons were pressed, no energy output generated.The device cannot be repaired as olympus does not provide repair to this device.Customer was informed about the unrepaired device.A supplemental will be submitted if additional information becomes available following investigation.

Event Description

It was reported that the device power plug that plug into the tower was observed with what seems to be something plastic inside.There was no patient involvement on this event.No user injury reported.

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.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11130730
• MDR Text Key: 225573987
• Report Number: 3011050570-2021-00007
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1