1588 AIM 1588210105Recalls & reported problems
Stryker Corporation · Camera Head, C-Mount · Class 2
All models of 1588 AIM (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker 1588 AIM camera head is a laparoscope camera head. The 40 reports that name it mostly describe blurry or lost images during procedures, including 2 injuries. There are no deaths. There are no recalls for 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
- 40
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613327174496), received between Oct 17, 2018 and Jan 25, 2024 — classified as 2 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (29 reports).
3 other recalls cover devices cleared under the same FDA submission (K132785); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image29
- No Display/Image11
- Product Quality Problem4
- Biocompatibility2
- Device Dislodged or Dislocated2
- Output Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient16
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580221 ↗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 17740907 ↗InjuryJun 13, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE VISUALIZATION DETERIORATED AND THE CASE WAS CONVERTED TO A OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17117715 ↗MalfunctionMay 19, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961299 ↗MalfunctionApr 12, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728643 ↗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 15982765 ↗MalfunctionJun 2, 2022No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14574405 ↗MalfunctionMay 9, 2022Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14337440 ↗MalfunctionApr 4, 2022Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14002365 ↗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 13693249 ↗MalfunctionFeb 23, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A POTENTIAL OF ADVERSE CONSEQUENCES DUE TO BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13588691 ↗MalfunctionJan 11, 2022No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13233273 ↗MalfunctionDec 30, 2021No Display/Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THAT THERE WAS LOSS OF VISUALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13120249 ↗MalfunctionNov 8, 2021Fluid/Blood Leak; Fluid/Blood Leak; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12775243 ↗MalfunctionNov 2, 2021Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741095 ↗MalfunctionNov 2, 2021Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741092 ↗MalfunctionNov 2, 2021Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741087 ↗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 12741086 ↗MalfunctionAug 31, 2021No Display/Image; Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12393867 ↗MalfunctionJun 10, 2021Output Problem; Output Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CASE WAS CANCELED AFTER THE PATIENT WAS PREPPED AND UNDER ANESTHESIA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11979450 ↗MalfunctionMar 11, 2021Output Problem; No Display/Image; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11463990 ↗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 11281075 ↗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 11281072 ↗MalfunctionJul 28, 2020Poor Quality Image; Device Dislodged or Dislocated; Poor Quality Image; Device Dislodged or Dislocated
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 10336167 ↗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 10336136 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132785. One submission often covers many models, so check the product and lot details in each record.
- Z-0569-2015 · Mar 5, 2013 · Terminated1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video
- Z-0571-2015 · Mar 5, 2013 · Terminated1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video
- Z-0570-2015 · Mar 5, 2013 · Terminated1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monit
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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