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 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Evaluation determined that the reported issue was confirmed.The connector receptor of the transducer was found damaged.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.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 during preparation for use the device was found with damaged transducer receptacle.The transducer was not recognized by the generator.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 report is a duplicate of patient identifier: (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide customer response and updates.Further communication with the customer conveyed the following information: the issue occurred after the procedure on (b)(6) 2020.According to the customer the procedure being performed was diagnostic.The name of the procedure performed was unable to be provided.There were no other devices involved in the event.There was no delay in the procedure.The intended procedure was completed.The same device was not used to complete the procedure.There were no other devices replaced during the procedure.The device will not be returned to olympus.The device is stored on a cart.It was inspected prior to use.No damage or abnormalities were observed.There was no resistance when plugging in the connector.No damage or impact was sustained to the connector.No further information was provided.

• 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: 11163682
• MDR Text Key: 250465104
• Report Number: 3011050570-2021-00014
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005016
• UDI-Public: 00855279005016
• 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: 02/12/2021

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-S
• 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: 12/16/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 02/12/2021
• Supplement Dates FDA Received: 02/02/2021; 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1