MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TELE PACK X LED

Model Number	TP100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that no light output coming from the unit and thus the vitom telescope could not be used.Failure of the unit occurred right before an outpatient procedure.The case had to be postponed.The patient was not harmed.No negative impact in state of health reported.

• Brand Name: TELE PACK X LED
• Common Device Name: TELE PACK X LED
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23960083
• Report Number: 2020550-2025-02479
• Device Sequence Number: 15814591
• Product Code: FET
• UDI-Device Identifier: 04048551322925
• UDI-Public: 04048551322925
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 01/05/2026
• Report Date (Section F): 01/05/2026

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: TP100
• Device Catalogue Number: TP100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2026
• 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