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

Model Number	TP101
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the stroboscopy output is not functioning.When the mic is connected and the footpedal is depressed, none of the on-screen readouts are portrayed.It remains blank and appears as if the mic and light are not tracking the mucosal wave.I have tried other mics and footpedals on that unit and they didn't work either and i also tried their mic and footpedal on another unit and it works fine.It was not possible to complete the stroboscopy portion of the procedure effectively.No negative impact in state of health reported.

• 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
• MDR Report Key: 25155677
• Report Number: 2020550-2026-00954
• Device Sequence Number: 9324337
• Product Code: FET
• UDI-Device Identifier: 04048551425701
• UDI-Public: 04048551425701
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 05/12/2026
• Report Date (Section F): 05/12/2026

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: TP101
• Device Catalogue Number: TP101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• 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