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 Codes	Hematoma (1884); Rupture (2208)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Treatment was of bilateral renal stones; 2600 shocks given to the left side and 1700 shocks given to the right side, both sides to a max power level of 6.Treatment was finished as a result of stone fragmentation, so no further treatment will be necessary.Device was tested onsite on april 6, 2021 and was found to be operational in accordance with karl storz service manual, and was returned to the customer for use.There were no issues reported with the equipment at the time of treatment, and the equipment has been utilized to perform treatments approximately 6 times since this reported incident.
Event or Problem Description
The customer reported that a patient was diagnosed with a ruptured kidney following eswl treatment on (b)(6) 2021 and was admitted to the hospital later that day.Patient was given 1 unit of blood in the er and has subsequently been given 2 more in icu.Hemoglobin is now stable at 7 for over 24 hrs and has been discharged from icu, but remains hospitalized for further evaluation.Patient is expected to fully recover.

• 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: 11682500
• Report Number: 9613347-2021-00038
• Device Sequence Number: 2999022
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: 7630039100230
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 04/06/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR