MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ COLD LIGHT FOUNTAIN XENON 100

Model Number	20132620-1
Medical Device Problem Codes	Off-Label Use (1494); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that when the concerned product was used in a veterinary procedure (laparoscopic spay).It was reported that "mid surgery the light source turned off and would not turn back on.The box was very hot to touch and only displayed the red warning light once the light had already gone out.As the light source would not turn back on after trying everything they suggested we had to convert to an open surgery which is not what the client had come in for." it was confirmed that the surgery was prolonged between 15 and 60 minutes and had to be converted from laparoscopic to open surgery.Furthermore, it was confirmed that there was no injury to the patient and the patient recovered well from the surgery as expected.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The investigation was completed on 2024-07-24.During investigation of the concerned cold light fountain xenon 100 scb several tests were performed to check the function of the device.During these tests no issues with the device were found and the xenon 100 always worked without any failures in function.The reported issue could not be duplicated.Please be aware that the reported case happened during use in a veterinary procedure, but the use of the concerned device is restricted to human medical applications.

• Brand Name: KARL STORZ COLD LIGHT FOUNTAIN XENON 100
• Common Device Name: LIGHT FOUNTAIN XENON 100
• 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
• MDR Report Key: 19136369
• Report Number: 9610617-2024-00113
• Device Sequence Number: 4720740
• Product Code: GCT
• UDI-Device Identifier: 04048551062838
• UDI-Public: 4048551062838
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20132620-1
• Device Catalogue Number: 20132620-1
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 07/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/17/2024; 08/01/2024
• 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
• Patient Sex: Unknown