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

Model Number	SPL-S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This report is being supplemented to inform that upon further review, this report is a duplicate of patient identifier: (b)(6).
Additional 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
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11163682
• Report Number: 3011050570-2021-00014
• Device Sequence Number: 3719623
• Product Code: FEO
• UDI-Device Identifier: 00855279005016
• UDI-Public: 00855279005016
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 02/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/02/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1