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

Model Number 20132620-1

Device Problems Off-Label Use (1494); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

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 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.

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).

• Brand Name: KARL STORZ COLD LIGHT FOUNTAIN XENON 100
• Type of Device: 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
• MDR Text Key: 341465730
• Report Number: 9610617-2024-00113
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04048551062838
• UDI-Public: 4048551062838
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20132620-1
• Device Catalogue Number: 20132620-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1