1788 1788610122Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker laparoscope is a rigid scope used in general and plastic surgery. The 30 reports mostly describe the camera producing no picture or image at all, along with flickering, poor quality images, connection problems, and loss of signal during procedures. No deaths or injuries are reported. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613327580044), received between Jan 4, 2024 and Sep 22, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (29 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
- No Display/Image29
- Output Problem6
- Poor Quality Image5
- Connection Problem3
- Erratic or Intermittent Display2
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862667 ↗MalfunctionSep 18, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831245 ↗MalfunctionSep 14, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764849 ↗MalfunctionSep 3, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576877 ↗MalfunctionSep 1, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549693 ↗MalfunctionAug 31, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534176 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532322 ↗MalfunctionAug 31, 2026No Display/Image
It was reported that there was picture issues/flickering with the camera.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532142 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532141 ↗MalfunctionAug 31, 2026Poor Quality Image
It was reported that there was bad image.
Patient problems: Insufficient Information
MAUDE report 50526583 ↗MalfunctionAug 12, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229355 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149872 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149869 ↗MalfunctionAug 3, 2026No Display/Image
It was reported that during the case the camera would intermittently drop out and then restart. Therefore, there was loss of image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124133 ↗MalfunctionMay 15, 2026No Display/Image; Output Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CAMERA HEAD WAS FLICKERING. THE DURATION OF LOSS OF IMAGE COULD NOT BE CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25192859 ↗MalfunctionMay 15, 2026No Display/Image; Output Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CAMERA HEAD WAS FLICKERING. HOWEVER, THE DURATION COULD NOT BE CONFIRMED, THEREFORE THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25192094 ↗MalfunctionApr 2, 2026No Display/Image; Output Problem
IT WAS REPORTED THAT IT WAS REPORTED THAT THE UNIT OCCASIONALLY ACTS UP, EITHER LOSING CONNECTION TO THE CCU OR FAILING THE WHITE BALANCE. THERE WAS A FULL LOSS OF IMAGE FOR A FEW MINUTES WHILE THE THE CAMERA HEAD WAS SWAPPED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765199 ↗MalfunctionApr 1, 2026No Display/Image; Output Problem
IT WAS REPORTED THAT IT WAS REPORTED THAT THE UNIT OCCASIONALLY ACTS UP, EITHER LOSING CONNECTION TO THE CCU OR FAILING THE WHITE BALANCE. THERE WAS A FULL LOSS OF IMAGE FOR A FEW MINUTES WHILE THE CAMERA HEAD WAS SWAPPED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24759399 ↗MalfunctionMar 19, 2026No Display/Image
IT WAS REPORTED THAT THE CAMERA THAT IS CUTTING OUT DURING SURGERY. THERE WAS FULL LOSS OF IMAGE AND THIS CAUSED A 5 MINUTE DELAY. A NEW DEVICE WAS USED TO COMPLETE THE MEDICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641427 ↗MalfunctionDec 22, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image
IT WAS REPORTED BY THE CUSTOMER THAT THE CAMERA WAS FLICKERING WHEN THE CABLE IS MOVED. THERE WAS PARTIAL IMAGE LOSS, REPLACEMENT DEVICE USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872866 ↗MalfunctionDec 19, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image
IT WAS REPORTED BY THE CUSTOMER THAT THE IMAGE FLICKERS WHEN THE CABLE IS MOVED. THERE WAS PARTIAL IMAGE LOSS, REPLACEMENT DEVICE USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855965 ↗MalfunctionDec 18, 2025No Display/Image; Output Problem; No Display/Image; Output Problem
IT WAS REPORTED THAT THE CAMERA HEAD IS DISCONNECTING WHEN THE CABLE IS MOVED NEAR THE CAMERA HEAD SIDE. THEREFORE THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information
MAUDE report 23843467 ↗MalfunctionJul 11, 2025No Display/Image; No Display/Image
THE UNIT FLICKERED MID CASE BACK TO THE "PLUG CAMERA IN" SCREEN. THEREFORE, THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22479973 ↗MalfunctionJun 24, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SCREEN INTERMITTENTLY LOST CONNECTION FOR 10¿20 SECONDS BEFORE COMING BACK ONLINE. EACH TIME THE CONNECTION COMES BACK, WHITE BALANCING WAS REQUIRED BEFORE THE PROCEDURE COULD CONTINUE. ADDITIONALLY, THE LIGHT WOULD INTERMITTENTLY CHANGE IN INTENSITY AND COLOR, ALSO REQUIRING WHITE BALANCING. INITIAL ACTIONS TAKEN INCLUDED FIXING, DISCONNECTING, AND RECONNECTING THE CAMERA HEAD AND HDMI PORT, AS WELL AS RESTARTING THE SYSTEM. THIS FIXED THE ISSUE TEMPORARILY. WHEN THE ISSUE RECURRED, THE CAMERA HEAD WAS REPLACED, WHICH APPEARED TO RESOLVE THE ISSUE FOR THE REMAINDER OF THE PROCEDURE. NO SURGICAL DELAY REPORTED OTHER THAN A FEW MINUTES TO SWAP THE CAMERA HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323605 ↗MalfunctionApr 29, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD HAS BEEN GOING IN AND OUT OF CONNECTION AND WHEN IT IS BENT A SPECIFIC WAY, IT LOSES CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928866 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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