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

Model Number	UL300-1
Medical Device Problem Codes	Device Fell (4014); 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
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.
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).
Additional Manufacturer Narrative
The device was returned to our us facility, and will later 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).
Additional Manufacturer Narrative
Per evaluation findings by the manufacturing site: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "on their third case using their calculase iii the screen froze and could not be reset by their team forcing them to abandon the procedure and then move the patient to a nearby facility for treatment.", could be confirmed.Upon closer inspection, it was determined that the front module (broken display) is defective.Caused by the user (falling damage already reported by customer).This should have been noticed before the operation.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.This event is filed under internal complaint id (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21869605
• Report Number: 9610617-2025-00637
• Device Sequence Number: 20812436
• Product Code: GEX
• UDI-Device Identifier: 08059173392278
• UDI-Public: 08059173392278
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K220426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 11/04/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/24/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown