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AIM (Advanced Imaging Modality) 0502537010Recalls & reported problems

Stryker Corporation · HD Laparoscope, Autoclavable, 0 View Direction · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327059342), received between Feb 9, 2023 and Sep 23, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (2 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Optical Problem2
  • Poor Quality Image2
  • Fogging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2026Fogging

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50876264 ↗
  • 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 17687316 ↗
  • MalfunctionJul 17, 2023Optical Problem; Optical Problem

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17339408 ↗
  • MalfunctionFeb 9, 2023Poor Quality Image; Optical Problem; Optical Problem

    IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16341605 ↗

Other Confocal optical imaging devices

All Confocal optical imaging devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.