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 Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly following the investigations.

Event Description

It was reported that the device was found with damaged cord, broken pins and would not work when plugged in.The issue occurred during reprocessing.There was no patient involvement on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to inform 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: 11225210
• MDR Text Key: 239094720
• Report Number: 3011050570-2021-00028
• 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: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1