NA 1688410105Recalls & reported problems
Stryker Corporation · AIM (Advanced Imaging Modality) 4K Autoclave Camera Head, C-Mount · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327562545), received between Feb 23, 2023 and Sep 29, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fogging” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fogging12
- Poor Quality Image6
- Erratic or Intermittent Display3
- Optical Decentration3
- Temperature Problem3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information6
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941049 ↗MalfunctionSep 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940827 ↗MalfunctionSep 3, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577004 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554567 ↗MalfunctionOct 2, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE IMAGE IS SHIFTED UP ON THE CAMERA. THERE WAS PARTIAL IMAGE LOSS WHEN THE IMAGE WAS CUT OFF.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23204073 ↗MalfunctionSep 29, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE IMAGE IS SHIFTED UP ON THE CAMERA. THERE WAS PARTIAL IMAGE LOSS WHEN THE IMAGE WAS CUT OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23174950 ↗MalfunctionFeb 24, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information
MAUDE report 21453455 ↗MalfunctionFeb 24, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information
MAUDE report 21453454 ↗MalfunctionFeb 24, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information
MAUDE report 21453453 ↗MalfunctionFeb 20, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information
MAUDE report 21426555 ↗MalfunctionFeb 20, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information
MAUDE report 21426554 ↗MalfunctionFeb 10, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351095 ↗MalfunctionMar 28, 2024Break; Fogging; Break; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18990025 ↗MalfunctionSep 6, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17691634 ↗MalfunctionSep 5, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17686503 ↗MalfunctionSep 5, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17685241 ↗MalfunctionJun 21, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170994 ↗MalfunctionJun 21, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170576 ↗MalfunctionJun 21, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170572 ↗MalfunctionJun 21, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170571 ↗MalfunctionMay 2, 2023Optical Decentration; Temperature Problem; Optical Decentration; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857690 ↗MalfunctionMay 2, 2023Optical Decentration; Temperature Problem; Optical Decentration; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16856187 ↗MalfunctionMay 2, 2023Optical Decentration; Temperature Problem; Optical Decentration; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855356 ↗MalfunctionFeb 23, 2023Poor Quality Image
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16427905 ↗
Other Endoscope, neurological devices
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
- VS3-IR 161-0001Visionsense Ltd. · Endoscope, Neurological1 recall4 reports
- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 reports
- NA 1688410110Stryker Corporation · Endoscope, neurological8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page