AIM (Advanced Imaging Modality) 0502537030Recalls & reported problems
Stryker Corporation · HD Laparoscope, Autoclavable, 30 View Direction · Class 2
Quick summary
This Stryker AIM HD laparoscope is used to view inside the body during minimally invasive surgery. The 24 reports on file all describe malfunctions, mostly the camera producing a foggy, blurry, or poor-quality image. No deaths and no injuries were reported. No recalls name this device.
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
- 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 07613327059373), received between Sep 3, 2019 and Aug 31, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (16 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
Most reported problems
Device problems
- Poor Quality Image16
- Fogging8
- Optical Problem7
- Misfocusing2
- Material Integrity Problem1
- Material Opacification1
- Optical Distortion1
- Optical Obstruction1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531003 ↗MalfunctionApr 22, 2025Fogging; Optical Distortion; Fogging; Optical Distortion
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882336 ↗MalfunctionApr 10, 2024Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084904 ↗MalfunctionJan 9, 2024Fogging; Optical Problem; Fogging; Optical Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18480554 ↗MalfunctionNov 22, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18195518 ↗MalfunctionNov 17, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159081 ↗MalfunctionSep 13, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17738917 ↗MalfunctionAug 8, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479883 ↗MalfunctionMar 10, 2023Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16524109 ↗MalfunctionMar 10, 2023Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16524098 ↗MalfunctionMar 10, 2023Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16523728 ↗MalfunctionMar 10, 2023Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16523724 ↗MalfunctionMar 8, 2023Poor Quality Image; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16509605 ↗MalfunctionNov 9, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15762742 ↗MalfunctionOct 19, 2022Fogging; Poor Quality Image; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635809 ↗MalfunctionSep 1, 2022Optical Obstruction; Poor Quality Image; Optical Obstruction
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15339502 ↗MalfunctionAug 15, 2022Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15224195 ↗MalfunctionAug 4, 2022Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15163117 ↗MalfunctionMay 7, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316956 ↗MalfunctionMar 8, 2022Fogging; Poor Quality Image; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13688817 ↗MalfunctionJun 28, 2021Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12076684 ↗MalfunctionAug 17, 2020Misfocusing; Poor Quality Image; Misfocusing
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10414567 ↗MalfunctionJul 14, 2020Misfocusing; Poor Quality Image; Misfocusing
IT WAS REPORTED THAT THERE WAS A POOR IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10273245 ↗MalfunctionSep 3, 2019Material Opacification
IT WAS REPORTED THE SCOPE WAS BLURRY DURING PROCEDURE A REPLACEMENT SCOPE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8956474 ↗
Other Confocal optical imaging devices
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EAOlympus Medical Systems Corp. · Confocal Optical Imaging1,110 reports
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200Olympus Medical Systems Corp. · Confocal Optical Imaging870 reports
- HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EBOlympus Medical Systems Corp. · Confocal Optical Imaging698 reports
- L11 0220230300Stryker Corporation · Confocal optical imaging233 reports
- L10 0220220300Stryker Corporation · Confocal optical imaging77 reports
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 reports
- SafeLight 0233050400Stryker Corporation · Confocal optical imaging56 reports
- 1588 AIM 1588010000Stryker Corporation · Confocal optical imaging35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.