MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE LITHOTRIPSY FOOTSWITCH; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-FS
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Event or Problem Description
As reported by the olympus territory manager for this event, the device remained active all the time.There is no reported harm to any patient.
Additional Manufacturer Narrative
Correction to d4 udi.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was inspected and the complaint was confirmed.The reported failure was due to a faulty electrical connection caused by a manufacturing process error.The current process does not have a routine checkout procedure to prevent product defects escaping the manufacturing floor.Although patient risk is low and the issue is contained to a single lot, a capa was assigned to implement corrections and preventative actions.The event can be detected by following the instructions for use which state: "perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance.Do not use a shockpulse-se system that fails to meet the criteria stated in the labeling or that has been damaged.Otherwise, injury to the patient, personnel and/or an adverse effect on the procedure could result." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information.
Event or Problem Description
Addendum apr 4, 2022: event occurred during set up with no patient involvement.This was the first time use of the device.The device was inspected before issue with no anomalies noted.

• Brand Name: SHOCKPULSE LITHOTRIPSY FOOTSWITCH
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 13998832
• Report Number: 3011050570-2022-00035
• Device Sequence Number: 11985706
• Product Code: FEO
• UDI-Device Identifier: 00821925043695
• UDI-Public: 00821925043695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/08/2022

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-FS
• Device Lot Number: FR189625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 05/10/2022; 06/08/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/08/2022; 06/06/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPL-GSPL-T
• Patient Sex: Unknown