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

Model Number	SPL-T
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device experienced an error code displayed when plugged into the transducer during set up.The issue was observed during preparation for use for a lithotripsy procedure to break down kidney stones.The procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device experienced an error code displayed when plugged into the transducer during set up.The issue was observed during preparation for use for a lithotripsy procedure to break down kidney stones.The procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d10 spl-g shockpulse lithotripsy generator sn# (b)(6).The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the transducer and generator exhibited poor connection and it was found to be worn out.No other issues were identified.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: component failure ¿ which is an expected or random component failure without any design or manufacturing issue.A device history record review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• 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: 19580232
• Report Number: 3011050570-2024-10177
• Device Sequence Number: 3315132
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPL-G SHOCKPULSE LITHOTRIPSY GENERATOR SN# (B)(6).; SPL-G SHOCKPULSE LITHOTRIPSY GENERATOR SN (B)(6).
• Patient Sex: Unknown