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

Model Number	SPL-T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that his olympus shockpulse lithotripsy transducer had a leak upon opening the package.There was no patient involvement during this event.
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
This is a supplemental report to correct the initial mdr.The initially selected intake code for suction issues (ltb5) does not exist for this model spl-t.Therefore, intake code has been replaced with suction issues (ltp44) to align with the reported device model.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 17817463
• Report Number: 3011050570-2023-00145
• Device Sequence Number: 11338236
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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-T
• Was Device Available for Evaluation?: No
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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