SDC3 0240060100Recalls & reported problems
Stryker Corporation · HD Information Management System · Class 2
Quick summary
This Stryker HD Information Management System is a surgical video system used with laparoscopes. Of its 83 reports, 82 are malfunctions and 1 is an injury, with no deaths. Most describe the image being lost or not displayed, along with poor image quality and output problems. 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
- 84
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 07613327056150), received between Oct 16, 2018 and Sep 25, 2026 — classified as 1 injury, 83 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (54 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
- No Display/Image54
- Output Problem34
- Image Display Error/Artifact10
- Poor Quality Image8
- Output below Specifications5
- Sparking4
- Application Program Problem3
- Connection Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Insufficient Information28
- No Known Impact Or Consequence To Patient21
- Injury1
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906077 ↗MalfunctionOct 30, 2024No Display/Image; Connection Problem; No Display/Image; Connection Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566897 ↗MalfunctionFeb 14, 2024Device Emits Odor; Temperature Problem; Device Emits Odor; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18707246 ↗MalfunctionJan 17, 2024No 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 18525838 ↗MalfunctionDec 22, 2023No 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 18383708 ↗MalfunctionDec 21, 2023No 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 18376780 ↗MalfunctionDec 13, 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 18320998 ↗MalfunctionOct 26, 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 18016510 ↗MalfunctionOct 19, 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 17967602 ↗MalfunctionSep 13, 2023No Display/Image; Image Display Error/Artifact; No Display/Image; Image Display Error/Artifact
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17740979 ↗MalfunctionAug 18, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS FULL LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17575419 ↗MalfunctionAug 17, 2023Device Emits Odor; Smoking; Device Emits Odor; Smoking
IT WAS REPORTED THAT THE DEVICE WAS EMITTING SMOKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17564104 ↗MalfunctionJun 21, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170563 ↗MalfunctionJun 19, 2023No Display/Image; Application Program Freezes or Fails to Launch; No Display/Image; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THERE WAS FULL LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17159104 ↗MalfunctionMay 16, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938811 ↗MalfunctionMay 10, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16907393 ↗MalfunctionMay 10, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16907392 ↗MalfunctionApr 18, 2023Connection Problem; Output Problem; Connection Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766082 ↗MalfunctionApr 13, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16736842 ↗MalfunctionMar 31, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16656887 ↗MalfunctionMar 30, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16649688 ↗MalfunctionMar 21, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16583758 ↗MalfunctionMar 17, 2023Connection Problem; Output Problem; Connection Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16565393 ↗MalfunctionDec 21, 2022Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16030493 ↗MalfunctionDec 15, 2022Output 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 15989073 ↗
Other Laparoscope, general & plastic surgery devices
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- 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
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.