1588 AIM 1588020122Recalls & reported problems
Stryker Corporation · Coupler, C-Mount, 18 mm · Class 2
All models of 1588 AIM (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker AIM coupler connects a surgical camera to a scope. Reports mostly describe blurry, foggy or otherwise poor image quality. There are 25 reports that mention its identifier, with no deaths and 1 injury. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327174359), received between Jun 19, 2019 and Sep 24, 2026 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (21 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
- Poor Quality Image21
- No Display/Image3
- Product Quality Problem3
- Biocompatibility2
- Device Dislodged or Dislocated2
- Erratic or Intermittent Display1
- Misfocusing1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient11
- Insufficient Information4
- No Code Available1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888689 ↗MalfunctionDec 4, 2024Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845800 ↗MalfunctionDec 6, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR QUALITY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18279509 ↗MalfunctionDec 14, 2022Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15982745 ↗MalfunctionNov 29, 2022Misfocusing; Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15882993 ↗MalfunctionMar 8, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13693164 ↗MalfunctionFeb 23, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A POTENTIAL OF ADVERSE CONSEQUENCE DUE TO BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13588623 ↗MalfunctionNov 2, 2021Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741184 ↗MalfunctionNov 2, 2021Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741093 ↗MalfunctionNov 2, 2021Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12741091 ↗MalfunctionNov 2, 2021Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12740969 ↗MalfunctionFeb 4, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE USER EXPERIENCED A MILD CHEMICAL BURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11281187 ↗MalfunctionFeb 4, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE USER EXPERIENCED MILD CHEMICAL BURNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11281040 ↗MalfunctionNov 2, 2020Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE AND A SURGICAL DELAY GREATER THAN 30 MINUTES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10775140 ↗MalfunctionSep 2, 2020Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10485664 ↗MalfunctionJul 28, 2020Poor Quality Image; Device Dislodged or Dislocated; Poor Quality Image; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE FOR ABOUT FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10336165 ↗MalfunctionJul 28, 2020No Display/Image; Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WAS IMAGE LOSS FOR ABOUT FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10336134 ↗MalfunctionJul 28, 2020Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THAT THERE WAS IMAGE LOSS FOR ABOUT FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10336133 ↗MalfunctionJul 28, 2020No Display/Image; Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WAS IMAGE LOSS FOR ABOUT FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10336128 ↗MalfunctionJul 28, 2020Poor Quality Image; Device Dislodged or Dislocated; Poor Quality Image; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE FOR ABOUT FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10336125 ↗MalfunctionMay 18, 2020Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10065951 ↗InjuryJul 3, 2019Poor Quality Image
IT WAS REPORTED THAT QUALITY OF THE PICTURE DETERIORATED AND LED TO CONVERSION TO AN OPEN PROCEDURE.
Patient problems: No Code Available
MAUDE report 8759042 ↗MalfunctionJul 2, 2019Poor Quality Image
IT WAS REPORTED THAT THE IMAGE WAS BLURRY DURING A PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8756100 ↗MalfunctionJun 19, 2019Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8713495 ↗MalfunctionJun 19, 2019Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8712741 ↗
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 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