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AIM (Advanced Imaging Modality) 0502937010Recalls & reported problems

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

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327063905), received between Aug 13, 2019 and Jul 18, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (5 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.

Most reported problems

Device problems

  • Poor Quality Image5
  • Optical Obstruction2
  • Optical Problem2
  • Fogging1
  • Misfocusing1
  • No Display/Image1
  • Optical Distortion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • No Known Impact Or Consequence To Patient2
  • Insufficient Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 18, 2023Optical Problem; Optical Problem

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17347284 ↗
  • MalfunctionMar 24, 2023Fogging; Fogging

    IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16616400 ↗
  • 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 16341560 ↗
  • MalfunctionDec 21, 2022Poor Quality Image

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16030548 ↗
  • MalfunctionApr 18, 2022Optical Distortion; No Display/Image; Optical Distortion

    IT WAS REPORTED THAT THERE WAS LACK OF IMAGE DURING PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14136229 ↗
  • MalfunctionDec 20, 2021Misfocusing; Poor Quality Image; Misfocusing

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13044392 ↗
  • MalfunctionMay 6, 2021Optical Obstruction; Optical Obstruction

    IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11787191 ↗
  • MalfunctionAug 12, 2020Poor Quality Image; Optical Obstruction; Poor Quality Image; Optical Obstruction

    IT WAS REPORTED THAT THERE WAS A FOGGY IMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10396227 ↗
  • MalfunctionAug 13, 2019Poor Quality Image

    IT WAS REPORTED THE IMAGE WAS BLURRY, A BACKUP DEVICE WAS USED TO COMPLETE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8888457 ↗

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.