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 Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Tac (technical customer center) support placed and ordered a new unit and accessories in replacement for the defective device for the customer.The subject device was not yet received for evaluation.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device shockpulse was found with a broken connector.The probe was found broken from the transducer unit.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.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Further communication with the customer conveyed the following information: the problem was first noted after the diagnostic procedure and no other devices were involved in the event.There was no delay and the procedure was completed with a different device (model and serial number unknown).The device is stored on a cart and inspected prior to use, no abnormalities were noted.There was no resistance plugging in the connector and no damage or impact was sustained.

• 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: 11151397
• MDR Text Key: 228074709
• Report Number: 3011050570-2021-00010
• 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,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-S
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1