MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MODULARIS VARIOSTAR; EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

Model Number	1157200
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer became aware of an event following a procedure on the modularis variostar unit.The extracorporeal shock wave lithotripsy (eswl) procedure was performed on a stone in the left kidney.The procedure was performed at 4000 shockwaves and 189 joules in total; average energy level used was at 3.7.Following the procedure the treated kidney stone looked disintegrated on an x-ray image.The physician communicated that the patient was bleeding from the left ureter.A small blister at the shockwave skin entrance was reported as well, however, according to the physician this nothing was out of the ordinary.Later it was noticed that the patient's spleen was bleeding.The spleen was surgically removed.The doctor indicated it was a rare complication of such procedure and was not assigning causality to the equipment itself.No failure or error of the urological device was reported.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Bleeding from the ureter after a kidney stone treatment is not unusual.No unusual injury to the skin where the shockwaves entered the body was reported.According to expert opinion of urologist, injury of the spleen is a very rare side effect of the eswl procedure.The spleen is located close to the left kidney and due to movement caused by breathing of the patient, a hematoma can be the result if high energy levels are used.In most cases this requires removal of the spleen.Typically 3000 - 3500 shock waves with an average energy level of 2,5 - 3,0 are used for kidney stone treatment.In the reported case 4000 shock waves with an average energy level of 3,7 were used, which is at the upper maximum limit recommended for kidney stone treatments.Therefore, user contribution can be assumed as the cause for the injury of the patient's spleen.The removal of the bleeding spleen in this case is classified as a serious injury.Even though no system malfunction was determined, the issue will be reported because of the associated injury.Internal id # (b)(4).

• Brand Name: MODULARIS VARIOSTAR
• Common Device Name: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 13904969
• Report Number: 3004977335-2022-21233
• Device Sequence Number: 4065296
• Product Code: LNS
• UDI-Device Identifier: 04056869008974
• UDI-Public: 04056869008974
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: 1157200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/25/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 75 KG