MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-S

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection of the device confirmed the reported failure.The device transducer receptacle was found damaged and cannot be plugged.Minor scratches and dents on the housing were observed.The reported issue was found to be due to damaged receptacle unit.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device transducer cannot plug into the generator.The front panel connector was found damaged.The issue occurred during preparation for use.

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-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11286026
• MDR Text Key: 230550045
• Report Number: 3011050570-2021-00042
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044197
• UDI-Public: 00821925044197
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1