MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM 29000; LITHOTRIPTER

Model Number	29000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was treated for 6mm left lower pole stone with 3000 shocks ramp up of energy to highest energy level of 5.No medication or homeopathic health aids reported to be taken prior to treatment.It was reported that patient received ketorolac interoperative.Patient developed pain/renal colic 20 mins after treatment and diagnosed with 10.3x5.5cm hematoma.Patient was admitted to the hospital on (b)(6) 2021 and was discharged on (b)(6) 2021.No report of treatment during hospital admission.Patient did not receive transfusion.Patient reported as recovered by treating physician, (b)(6).Physician reported no issues with the equipment at the time of treatment.Device was evaluated onsite on oct 20th.No issues were found; device tested within specifications, and device was returned to the customer for use.Hematomas are known side-effect of eswl treatment.
Event or Problem Description
The customer reported that a patient presented with a hematoma following eswl treatment on (b)(6) 2021.The patient was admitted to the hospital on (b)(6) 2021 and was discharged in stable condition on (b)(6) 2021.

• Brand Name: MODULITH SLX-F2 180MM 29000
• Common Device Name: LITHOTRIPTER
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfesstrasse 8; taegerwilen, 8274 ; SZ 8274
• MDR Report Key: 12668553
• Report Number: 9613347-2021-00039
• Device Sequence Number: 11126507
• Product Code: LNS
• UDI-Device Identifier: 07630039100919
• UDI-Public: 7630039100919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 29000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/20/2021
• 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
• Patient Age: 50 YR