MAUDE Adverse Event Report: CYBERSONICS INC. SHOCKPUL SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX); ELECTROHYDRAULIC LITHOTRIPTOR

Model Number	SPL-PD376
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pouch of the subject device is requested from the customer.Following additional information is shared by the customer: "one person carried the box into the operating room and pulled out one probe from the box and discovered it was open at the top by the peel area.The other 2 were inspected from the box and were intact.No pictures are available right now." ifu instructs to inspect the product/package for any damage."do not use if package is damaged" symbol is on label of the product and also in the ifu.If significant additional information is received, this report will be supplemented.
Event or Problem Description
"spl-pd376 sterile packaging was open upon opening outer box.No patient involvement.".

• Brand Name: SHOCKPUL SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX)
• Common Device Name: ELECTROHYDRAULIC LITHOTRIPTOR
• Manufacturer (Section D): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• MDR Report Key: 7564805
• Report Number: 3004216443-2018-00001
• Device Sequence Number: 19381864
• Product Code: FEO
• UDI-Device Identifier: 00855279005030
• UDI-Public: (01)00855279005030(17)230205(10)D1800854
• Combination Product (Y/N): N
• PMA/510(K) Number: K171024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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 Expiration Date: 02/05/2023
• Device Model Number: SPL-PD376
• Device Lot Number: D1800854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1