MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CALCULASE III

Model Number	UL300-1
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a veterinary procedure (information of case date or type was not provided), the device screen froze and could not be reset by the team forcing them to abandon the procedure.The animal patient was then moved to a nearby facility for treatment.No further information was provided.

• Brand Name: CALCULASE III
• Common Device Name: CALCULASE III
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 21869606
• Report Number: 2020550-2025-00637
• Device Sequence Number: 15432946
• Product Code: GEX
• UDI-Device Identifier: 08059173392278
• UDI-Public: 08059173392278
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025
• Report Date (Section F): 04/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UL300-1
• Device Catalogue Number: UL300-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• 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 Sex: Unknown