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

Model Number	TP101
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, intermittent signal interruptions occurring.The signal interruptions occurred during a presentation of the device with the staff and not during a medical procedure, there was no patient involved.No death or (unanticipated) serious deterioration in state of health reported.Cross reference mdr: 2027009-2026-00095.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: section h6 has been updated to included additional codes.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TELE PACK +
• Common Device Name: TELE PACK +
• 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: 24141589
• Report Number: 9610617-2026-00094
• Device Sequence Number: 9357508
• Product Code: FET
• UDI-Device Identifier: 04048551425701
• UDI-Public: 04048551425701
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221174
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2026

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: TP101
• Device Catalogue Number: TP101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 06/15/2026; 06/15/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 06/12/2026; 06/19/2026; 06/22/2026
• 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