1688 1688210105Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker laparoscope is an endoscope used to see inside the body during keyhole surgery. Of its 78 reports, 74 are malfunctions and 4 are injuries, with no deaths. Many describe poor image quality, fogging, or the picture disappearing or flickering. 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
- 85
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 07613327418989), received between May 21, 2020 and Sep 16, 2026 — classified as 3 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (34 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image34
- No Display/Image18
- Erratic or Intermittent Display15
- Output Problem11
- Fogging10
- Temperature Problem4
- Insufficient Device Problem Information3
- Optical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- Insufficient Information20
- No Known Impact Or Consequence To Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782378 ↗MalfunctionSep 15, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782170 ↗MalfunctionSep 11, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744576 ↗MalfunctionSep 11, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741853 ↗MalfunctionSep 9, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702917 ↗MalfunctionSep 9, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700272 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576726 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576498 ↗MalfunctionAug 31, 2026Poor Quality Image
It was reported that the image was too bright, and that they were unable to see. Therefore, there was overexposed image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532437 ↗MalfunctionAug 27, 2026No Display/Image
It was reported that the camera is randomly disconnecting from the Stryker system. Therefore, there was loss of image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487991 ↗MalfunctionAug 24, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422063 ↗MalfunctionAug 24, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419594 ↗MalfunctionAug 20, 2026No Display/Image
It was reported that the device was glitching and loosing the image. There was a surgical delay of about 3-5 minutes to obtain a replacement to finish the medical procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50335618 ↗MalfunctionAug 18, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311073 ↗MalfunctionAug 12, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229351 ↗MalfunctionAug 12, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229348 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150119 ↗MalfunctionAug 5, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149380 ↗MalfunctionNov 26, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR LOSS OF IMAGE DUE TO THE MONITOR FLICKERING BECAUSE THE DURATION OF FULL LOSS OF IMAGE COULD NOT BE CONFIRMED. UPON ADDITIONAL INFORMATION PROVIDED, THIS EVENT IS NO LONGER REPORTABLE AS IT WAS CONFIRMED THAT THE FLICKERING WAS OBSERVED ON RIGHT SIDE OF THE MONITOR AND THAT THERE WAS NO FULL LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660667 ↗MalfunctionNov 19, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS HEATING DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598671 ↗MalfunctionOct 16, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT WHEN PREPARING DEVICES FOR USE, CAMERA AND CONSOLE, THERE WAS NO PICTURE. SALES REP HAS BEEN CONTACTED BY THE PHONE AND DECIDED TO INSPECT THE DEVICES IN PERSON. AFTER MANY TRIES IT WAS NOT POSSIBLE TO GET A PICTURE. IT WAS DECIDED TO SEND PRODUCTS TO TECHNICAL SERVICE.
Patient problems: Insufficient Information
MAUDE report 23318041 ↗MalfunctionAug 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS A VISION PROBLEM. THEREFORE, THERE WAS POOR IMAGE QUALITY.
Patient problems: Insufficient Information
MAUDE report 22925137 ↗MalfunctionAug 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS AN IMAGE CLARITY ISSUE.
Patient problems: Insufficient Information
MAUDE report 22878054 ↗MalfunctionJun 25, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information
MAUDE report 22331521 ↗MalfunctionApr 22, 2025Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21886357 ↗
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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