NA 72200315FRecalls & reported problems
Smith & Nephew, Inc. · 19.5 MM HIGH DEFINITION ENDOCOUPLER, C-MOUNT, BLACK RING - 560H HEAD ONLY REFURBISHED · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554024593), received between May 24, 2024 and Sep 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Optical Distortion” (1 report).
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
- Optical Distortion1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING A PROCEDURE, THE COUPLER WAS STUCK WITH THE CAMERA HEAD. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166377 ↗MalfunctionMay 24, 2024Optical Distortion; Optical Distortion
IT WAS REPORTED THAT, DURING SURGERY, THE CAMERA COUPLER DISPLAYED A FLICKERING IMAGE. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19393374 ↗
Other INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE devices
- Zoom coupler Arthrex 14-29mm C-Mount E240W.O.M. World of Medicine GmbH · Instrument, Special Lens, For Endoscope4 reports
- NA 72200315Smith & Nephew, Inc. · INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE1 report
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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