1488 1488210105Recalls & reported problems
Stryker Corporation · 3-HD Chip Camera Head, C-Mount · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker camera head is used with laparoscopes for general and plastic surgery. The 24 reports mostly describe loss of image or foggy and blurry images during procedures, with 1 report mentioning shock and a burn. There were no deaths and 1 injury, and 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327061055), received between Jun 24, 2019 and Apr 7, 2025 — classified as 1 injury, 23 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (12 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
- No Display/Image12
- Poor Quality Image7
- Optical Problem5
- Electrostatic Discharge2
- Fogging2
- Output Problem2
- Adverse Event Without Identified Device or Use Problem1
- Environmental Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information8
- No Known Impact Or Consequence To Patient4
- Electric Shock1
- Shock from Patient Lead(s)1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2025No Display/Image; Output Problem; No Display/Image; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21793364 ↗MalfunctionMar 23, 2024Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18965376 ↗MalfunctionMar 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18965365 ↗MalfunctionSep 22, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17801197 ↗MalfunctionJun 14, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17131861 ↗MalfunctionFeb 9, 2023Poor 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 16342759 ↗MalfunctionFeb 9, 2023Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16341622 ↗MalfunctionOct 3, 2022No Display/Image; Optical Problem; Output Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15527389 ↗MalfunctionSep 24, 2022Optical Problem; No Display/Image; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15475506 ↗MalfunctionJul 28, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15126937 ↗MalfunctionMay 27, 2022No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14522399 ↗MalfunctionMay 18, 2022Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14429785 ↗MalfunctionJan 6, 2022No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177871 ↗MalfunctionAug 26, 2021Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12372275 ↗MalfunctionAug 17, 2021No Display/Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12334446 ↗InjuryApr 28, 2021Gas/Air Leak; Excessive Heating; Gas/Air Leak; Excessive Heating
IT WAS REPORTED THAT THE USER WAS BURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn
MAUDE report 11737213 ↗MalfunctionJan 28, 2021No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11248154 ↗MalfunctionJan 21, 2021Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrostatic Discharge
IT WAS REPORTED THE USER WAS SHOCKED.
Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions
MAUDE report 11211364 ↗MalfunctionSep 2, 2020No Display/Image; Environmental Compatibility Problem; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10485667 ↗MalfunctionJul 23, 2020Poor Quality Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10317747 ↗MalfunctionJun 29, 2020Poor Quality Image; Poor Quality Image
IT WAS REPORTED THERE WAS LOSS OF IMAGE FOR A MINUTE OR LESS DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10209939 ↗MalfunctionFeb 24, 2020Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge
IT WAS REPORTED THAT A USER WAS SHOCKED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 9745443 ↗MalfunctionAug 13, 2019No Display/Image
IT WAS REPORTED THAT THERE WAS A LOSS OF VISUALIZATION AND SURGICAL DELAY GREATER THAN 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8888453 ↗MalfunctionJun 24, 2019No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE. PER ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT CAMERA HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8729383 ↗
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-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-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-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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