n.a. WD300Recalls & reported problems
Karl Storz GmbH & Co. KG · KARL STORZ AIDA · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551415320), received between Jun 18, 2024 and Mar 5, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).
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
Most reported problems
Device problems
- Display or Visual Feedback Problem1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
- No Display/Image1
- Output Problem1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2025Loose or Intermittent Connection; Output Problem; Loose or Intermittent Connection; Output Problem
IT WAS REPORTED THAT THE DEVICE WAS NOT DISPLAYING IMAGE ON THE SMARTSCREEN, THE UNIT DID NOT TURN OFF OR ON. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526429 ↗MalfunctionFeb 6, 2025No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information
IT WAS REPORTED THAT LOSS OF IMAGE ON SURGICAL MONITOR 2 LOTS OR1AIR HAPPENED AT THE SAME TIME IN THE SAME THEATRE ON THE SAME PATIENT. THERE WAS A TEMPORARY BLANK SCREEN FOR APPROX. 15 SECONDS WHILST SURGERY WAS IN PROGRESS THERE WAS A FAULTY MONITOR - FURTHER INVESTIGATION NEEDED AS THIS MAY ALSO BE AS A RESULT OF AN ISSUE WITH THE TC201EN, OR TH120, OR OR1AIR (WD300 / AVM). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00147. 9610617-2025-00148.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329694 ↗MalfunctionFeb 6, 2025Display or Visual Feedback Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025 (CASE TYPE INFORMATION WAS NOT PROVIDED), THE RECORDING DEVICE IMAGE CUT OFF AND THE SCREEN GOES BLACK. THE DEVICE THEN SHUT OFF ITSELF AND CANNOT BE RESTARTED. SINCE THIS DEVICE IS RECORDING DEVICE, THEY WERE STILL ABLE TO COMPLETE THE PROCEDURE USING THE MAIN OR MONITOR WITHOUT ANY PATIENT IMPACT,
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21329609 ↗InjuryJun 18, 2024Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT DURING A CASE, THE NURSE WAS SHOCKED WHEN TOUCHING THE AIDA BELLA SMARTSCREEN. NO OTHER INFORMATION WAS PROVIDED, OTHER THAN THERE WAS NO INJURY TO THE NURSE NOR THE PATIENT REPORTED, NOR ANY OTHER IMPACT TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563694 ↗
Other System, digital image communications, radiological devices
- CALLISTO eye Panel PC Model IICarl Zeiss Meditec AG · System, Digital Image Communications, Radiological1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.