MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR; LITHOTRIPTOR,

Model Number	25000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient was being treated for 3 renal calculi measuring 3mm respectively.Treatment was delivered at 120 shocks per minute at energy level of 4; a total of 1471 shocks were delivered.Patient passed away before eswl treatment was completed.No other information was disclosed.There were no issues with the modulith slx-f2 reported prior to, during, or after reported incident.Device was evaluated onsite the following day, (b)(6) 2021; no issues were found with the modulith slx-f2 device, and device was returned to the customer for use.
Event or Problem Description
We learned that a patient passed away during an extracorporeal shock wave lithotripsy procedure at (b)(6) hospital ada, in ada, (b)(6) on (b)(6) 2021.

• Brand Name: MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR
• Common Device Name: LITHOTRIPTOR,
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; tägerwilen, 8274 ; SZ 8274
• MDR Report Key: 11227277
• Report Number: 9613347-2021-00015
• Device Sequence Number: 4104352
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: 7630039100230
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25000
• Device Catalogue Number: 25000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 89 YR