AIM (Advanced Imaging Modality) 0502937030Recalls & reported problems
Stryker Corporation · HD Laparoscope, Autoclavable, 30 View Direction · Class 2
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327063912), received between Jun 3, 2019 and Aug 27, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (8 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
- Optical Problem8
- Fogging6
- Poor Quality Image5
- Break3
- Moisture or Humidity Problem3
- Optical Distortion2
- Optical Obstruction2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information9
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT FOGGING WAS NOTICED DURING THE SURGICAL PROCEDURE. INITIALLY, AFTER INSERTION INTO THE PERITONEAL CAVITY, VISUALIZATION WAS NORMAL. DESPITE OUR ATTEMPTS, WE WERE UNABLE TO IMPROVE THE IMAGE QUALITY. AFTER REPLACING THE OPTICS, THE IMAGE RETURNED TO NORMAL. THE PATIENT WAS A 66-YEAR-OLD FEMALE WEIGHING 66 KG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904944 ↗MalfunctionNov 15, 2024Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696048 ↗MalfunctionJan 17, 2024Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531054 ↗MalfunctionJan 17, 2024Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18530888 ↗MalfunctionDec 21, 2023Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380191 ↗MalfunctionOct 19, 2023Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17968221 ↗MalfunctionAug 18, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17579668 ↗MalfunctionJun 29, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17228726 ↗MalfunctionMar 13, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16529270 ↗MalfunctionFeb 1, 2023Display or Visual Feedback Problem; Optical Distortion; Optical Distortion
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16276886 ↗MalfunctionNov 30, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE TIP OF THE SCOPE FELL OFF. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15888120 ↗MalfunctionOct 10, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15573098 ↗MalfunctionJul 28, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15126784 ↗MalfunctionMar 8, 2022Poor Quality Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13688802 ↗MalfunctionJan 26, 2022Fogging; Fogging; Poor Quality Image
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13362045 ↗MalfunctionNov 10, 2021Optical Problem; Optical Obstruction; Optical Problem; Optical Obstruction
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12789408 ↗MalfunctionNov 1, 2021Optical Problem; Optical Obstruction; Optical Problem; Optical Obstruction
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12729439 ↗MalfunctionMay 18, 2021Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11843380 ↗MalfunctionApr 22, 2021Break; Break
IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE INSIDE OF THE PATIENT; PLEASE NOTE, ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11710375 ↗MalfunctionDec 10, 2020Break; Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP BROKE INSIDE OF THE PATIENT. PLEASE NOTE, ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10984470 ↗MalfunctionJul 15, 2019Fogging
IT WAS REPORTED SCOPE WAS FOGGING DURING CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8789684 ↗MalfunctionJun 3, 2019Material Opacification
IT WAS REPORTED THE SCOPE WAS FOGGY DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8664407 ↗
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.