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	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the foot switch continuously self-activated while foot switch was connected, and the connector pins and cable failed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the shockpulse system was activated continuously (non-stop) when using the foot pedal when it was not pressed on the shockpulse lithotripsy footswitch.When the shockpulse system was tested with hand activation, it worked correctly.The issue was found during an outpatient procedure.The procedure was completed by switching to hand activation.There were no reports of patient harm.
Additional Manufacturer Narrative
Additional information based on customer follow-up response was added to section b5.
Event or Problem Description
Additional information reported by the customer states that the name of the procedure was percutaneous nephrolithotripsy (pcnl).There was no delay in the procedure.The patient was under general anesthesia.The procedure was not completed as the patient's condition was not good (not caused by the device).
Additional Manufacturer Narrative
Corrected the unique identifier number (udi) in section d4 to: (b)(4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h10 of the initial medwatch report.The device evaluation did not confirm/duplicate the customer's allegation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, as the device evaluation did not confirm the reported issue, and the device functioned as intended, a specific root cause could not be identified.The event can be detected/prevented by following the inspection method for the event is described as follows in the instructions for use: "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.

• Brand Name: SHOCKPULSE LITHOTRIPSY FOOTSWITCH
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16000357
• Report Number: 3011050570-2022-00129
• Device Sequence Number: 15123052
• Product Code: FEO
• UDI-Device Identifier: 00821925043695
• UDI-Public: 00821925043695
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2023

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: FR197866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 05/15/2023; 05/15/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/22/2023; 06/01/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown