1688 1688010000Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker 1688 laparoscope is a scope used for minimally invasive surgery. Many of its 288 reports describe no image or a poor quality image on the monitor, and some describe the picture appearing upside down or the camera control unit rebooting during surgery. The reports include 5 injuries and no deaths. One open recall began in January 2022 and concerns a software error in the camera control unit that can flip the image upside down.
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
- 308
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 308 adverse event reports that list this exact device (DI 07613327420081), received between Apr 1, 2019 and Sep 29, 2026 — classified as 5 injuries, 303 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (158 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jan 14, 2022Class IIOpen, Classified
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
Z-0728-2022 · Root cause: Software in the Use Environment · Recall details · FDA record ↗
Most reported problems
Device problems
- No Display/Image158
- Poor Quality Image108
- Output Problem47
- Image Orientation Incorrect16
- No Device Output15
- Optical Problem10
- Overheating of Device10
- Connection Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions279
- Insufficient Information57
- No Known Impact Or Consequence To Patient21
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
Recent adverse event reports
The 25 most recent of 308 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940529 ↗MalfunctionSep 25, 2026No Display/Image
It was reported that the camera box was sending a very dim signal, then a static/fuzzy signal, and then no longer reading an input from the camera. Therefore, there was a full loss of image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898519 ↗MalfunctionSep 23, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872776 ↗MalfunctionSep 17, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810401 ↗MalfunctionSep 16, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796744 ↗MalfunctionSep 15, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782172 ↗MalfunctionSep 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765690 ↗MalfunctionSep 14, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764846 ↗MalfunctionSep 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744452 ↗MalfunctionSep 11, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743712 ↗MalfunctionSep 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707026 ↗MalfunctionSep 9, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701509 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576147 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575575 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575113 ↗MalfunctionSep 2, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575105 ↗InjuryAug 28, 2026No Display/Image
It was reported that during surgery, the arthroscopic image was no longer displayed on the monitor. The arthroscopy camera system was restarted in an attempt to restore the image; however, only the arthroscopic image was not displayed. The procedure was changed from an arthroscopic technique to a semi-open technique, and the surgery was resumed. The surgery was completed. The surgery was interrupted for approximately 30 minutes due to a malfunction of the camera system. The event occurred while the patient was under general anesthesia.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507656 ↗MalfunctionAug 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506510 ↗MalfunctionAug 26, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462066 ↗MalfunctionAug 24, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419595 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245094 ↗MalfunctionAug 12, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230104 ↗MalfunctionAug 12, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230042 ↗MalfunctionJul 16, 2026No Display/Image; No Device Output
IT WAS REPORTED THAT THE UNIT LOSING POWER AND TURNING OFF DURING THE CASE. THEREFORE, THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847446 ↗MalfunctionJul 16, 2026No Display/Image; No Device Output
IT WAS REPORTED THAT THE UNIT LOSING POWER AND TURNING OFF DURING THE CASE. THEREFORE, THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847444 ↗
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 · each recall links to the FDA recall notice
- 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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