660HD 72200242S3ERecalls & reported problems
Smith & Nephew, Inc. · SVCE REPL 3RD EDITION 660IMS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885554030846), received between Nov 13, 2017 and Oct 8, 2021 — classified as 8 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (2 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.
Most reported problems
Device problems
- No Display/Image2
- Reset Problem2
- Application Program Freezes or Fails to Launch1
- Device Emits Odor1
- Device Operates Differently Than Expected1
- Loss of Power1
- Overheating of Device1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPE, THE IMAGE MANAGEMENT SYSTEM STARTED TO SMELL LIKE BURNING AND OVERHEATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12600177 ↗MalfunctionJan 22, 2019Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE FREEZES INTERMITTENTLY DUE TO THE SYSTEM WAS LOCKING UP. IT IS UNKNOWN IF THERE WAS A DELAY OR A BACKUP DEVICE AVAILABLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8268374 ↗MalfunctionDec 13, 2018Reset Problem
IT WAS REPORTED THAT DURING SHOULDER SURGERY THE DEVICE REBOOTED.THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8160746 ↗MalfunctionJul 16, 2018Reset Problem
IT WAS REPORTED THAT THE DEVICE DISPLAYED A RESET DATE EVERY TIME. OCCURRED DURING PROCEDURE. NO DELAY WAS REPORTED, NO BACK-UP DEVICE WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7690260 ↗MalfunctionJun 29, 2018Loss of Power; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE DEVICE SHUT DOWN, CAUSING LOSS OF VISUALIZATION DURING SURGERY. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7653367 ↗MalfunctionMay 3, 2018No Display/Image
IT WAS REPORTED THAT THE SCREEN WOULD GO BLACK MID CASE. EVENT OCCURRED DURING A KNEE SURGERY. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7484833 ↗MalfunctionJan 12, 2018No Display/Image
IT WAS REPORTED THAT SCREEN AND UNIT WENT BLACK. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7186845 ↗MalfunctionNov 13, 2017Device Emits Odor
IT WAS REPORTED THAT THE 600IMS HAD A BURNING SMELL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7026732 ↗
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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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