TELE PACK TP101Recalls & reported problems

Karl Storz GmbH & Co. KG · TELE PACK + · Class 2

Quick summary

This Karl Storz Tele Pack is a video imaging unit used with endoscopes in gastroenterology and urology. The 42 reports that mention its identifier mostly describe display problems such as blank or intermittent images and error messages, with

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 41
Deaths reported: 0
Injuries reported: 14
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04048551425701), received between Feb 19, 2025 and Sep 21, 2026 — classified as 14 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Erratic or Intermittent Display9
Electrical /Electronic Property Problem6
No Apparent Adverse Event5
No Display/Image5
Data Problem4
Defective Component3
Defibrillation/Stimulation Problem2
Detachment of Device or Device Component2

Patient problems

No Clinical Signs, Symptoms or Conditions35
Insufficient Information6

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 21, 2026No Display/Image
The following was reported: "8-pin connector difficult to connect scopes and scope will intermittently lose image- tested with multiple flexible scopes." No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842515 ↗
MalfunctionAug 31, 2026Loose or Intermittent Connection
According to the information received, warranty issue: Error message "Menu temporarily unavailable." Resulting in no image when scope plugged in. No death or (unanticipated) serious deterioration in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524656 ↗
MalfunctionJul 29, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075728 ↗
MalfunctionJul 29, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075725 ↗
MalfunctionJul 28, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060726 ↗
MalfunctionJul 17, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25860709 ↗
MalfunctionJul 16, 2026Optical Distortion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841953 ↗
MalfunctionJul 7, 2026Erratic or Intermittent Display
IT WAS REPORTED: "INTERMITTENT IMAGE IN THE C-PORT, NO IMAGES ON SLIMLINE AND SINGLE USE SCOPES. ALL SCOPES HAVE IMAGES ON THE OTHER TELEPAK". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736521 ↗
MalfunctionJul 7, 2026Loose or Intermittent Connection
THE FOLLOWING WAS REPORTED: "DISPLAYING AN INTERNAL ERROR MESSAGE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736513 ↗
MalfunctionJun 16, 2026Erratic or Intermittent Display
IT WAS REPORTED "CAMERA SOCKET ISSUES - IMAGES CUT OUT INTERMITTENTLY, INTERMITTENT CAMERA HEAD NOT RECOGNISED ERROR MESSAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521741 ↗
InjuryMay 12, 2026Defibrillation/Stimulation Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155679 ↗
InjuryMay 12, 2026Defibrillation/Stimulation Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155677 ↗
MalfunctionMar 13, 2026Output Problem
THE FOLLOWING WAS REPORTED: "PROVIDING ERROR MESSAGE UPPER RIGHT CORNER - SYSTEM NOT RESPONDING PLEASE CYCLE IF ISSUE PERSIST." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591110 ↗
InjuryMar 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT "GETTING MENU TEMPORARILY UNAVAILABLE MESSAGE CONTINUOUSLY, ETHERNET PORT DAMAGED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, THEY WERE NOT ABLE TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539077 ↗
InjuryMar 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT "GETTING MENU TEMPORARILY UNAVAILABLE MESSAGE CONTINUOUSLY, ETHERNET PORT DAMAGED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, THEY WERE NOT ABLE TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538918 ↗
InjuryMar 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT "GETTING MENU TEMPORARILY UNAVAILABLE MESSAGE CONTINUOUSLY, ETHERNET PORT DAMAGED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, THEY WERE NOT ABLE TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538904 ↗
InjuryMar 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT "GETTING MENU TEMPORARILY UNAVAILABLE MESSAGE CONTINUOUSLY, ETHERNET PORT DAMAGED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, THEY WERE NOT ABLE TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538827 ↗
InjuryMar 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT "GETTING MENU TEMPORARILY UNAVAILABLE MESSAGE CONTINUOUSLY, ETHERNET PORT DAMAGED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, THEY WERE NOT ABLE TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538747 ↗
MalfunctionFeb 25, 2026Optical Distortion
IT WAS REPORTED THAT FAULTS: DISPLAY GOES BLANK INTERMITTENTLY DURING PROCEDURE, THE PROCEDURE WAS EXTENDED LESS THAN 30 MINUTES AND THE HOSPITAL STAY WAS NOT EXTENDED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24449392 ↗
MalfunctionFeb 24, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT "FAULTS: DISPLAY GOES BLANK INTERMITTENTLY DURING PROCEDURE, THE PROCEDURE WAS EXTENDED LESS THAN 30 MINUTES AND THE HOSPITAL STAY WAS NOT EXTENDED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436873 ↗
MalfunctionFeb 12, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT "THE IMAGE ON THE SCREEN IS FLASHING AND CUTS OUT". ACCORDING TO THE INFORMATION RECEIVED, THIS HAPPENED DURING A VETERINARY PROCEDURE AND THE PROCEDURE COULD BE COMPLETED WITH A PROLONGATION OF LESS THAN 15 MINUTES. THERE WAS NO INJURY OR IMPACT TO ANY HUMAN REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE PRODUCT CONCERNED (TP101) IS ALSO INTENDED FOR USE DURING HUMAN MEDICAL PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321245 ↗
MalfunctionJan 30, 2026No Display/Image
IT WAS REPORTED: "NO IMAGE / ERROR MESSAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226186 ↗
InjuryJan 21, 2026Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED: "ONE SIDE OF THE OUTER SHEATH'S LOCKING PLATE DISLODGED INTO THE BODY. IT WAS IMMEDIATELY RETRIEVED, BUT THE OTHER SIDE WAS FOUND MISSING. NO SHADOW WAS VISIBLE ON X-RAY, LEADING TO A DETERMINATION THAT IT WAS NOT PRESENT. IT IS HIGHLY LIKELY THAT IT HAD BEEN DAMAGED PREVIOUSLY."
Patient problems: Insufficient Information
MAUDE report 24141598 ↗
InjuryJan 21, 2026Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED: "ONE SIDE OF THE OUTER SHEATH'S LOCKING PLATE DISLODGED INTO THE BODY. IT WAS IMMEDIATELY RETRIEVED, BUT THE OTHER SIDE WAS FOUND MISSING. NO SHADOW WAS VISIBLE ON X-RAY, LEADING TO A DETERMINATION THAT IT WAS NOT PRESENT. IT IS HIGHLY LIKELY THAT IT HAD BEEN DAMAGED PREVIOUSLY."
Patient problems: Insufficient Information
MAUDE report 24141597 ↗
MalfunctionJan 21, 2026Erratic or Intermittent Display; No Apparent Adverse Event
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24141589 ↗

Device details

UDI-DI	`04048551425701`
Brand	TELE PACK
Model	TP101
Company	Karl Storz GmbH & Co. KG
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 1, 2024

Device type (GMDN): Endoscopic video image processing/light source system

A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.