NA 72200315Recalls & reported problems
Smith & Nephew, Inc. · 19.5 MM HIGH DEFINITION ENDOCOUPLER, C-MOUNT, BLACK RING - 560H HEAD ONLY · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010590688), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE COUPLER HAD AN INCORRECT SERIAL NUMBER COMPARED WITH THE SAP INFORMATION. COUPLER SHOWS PART NO: 72200315 AND SERIAL NO: (B)(4) BUT SAP IDENTIFIES THAT SERIAL NUMBER ONLY FOR PART NO: 72200422. INCIDENT OCCURRED DURING A FUNCTIONALLY CHECK; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057044 ↗
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 72200315FSmith & Nephew, Inc. · INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE2 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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