N/A 72205149Recalls & reported problems
Smith & Nephew, Inc. · 4KO VIDEO ARTHRSCP AC 4X30 DEGREE X160MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556735954), received between Apr 8, 2021 and Feb 3, 2026 — classified as 2 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Crack” (11 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
- Crack11
- Optical Obstruction2
- Break1
- Dent in Material1
- Material Integrity Problem1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Break; Crack; Dent in Material; Material Integrity Problem; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT, DURING SURGERY, ONE (1) 4KO VIDEOARTHROSCOPE WAS CRACKED. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MIN., USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247172 ↗MalfunctionJun 9, 2021Crack; Crack
IT WAS REPORTED THAT DURING A KNEE SCOPE, THE SCOPE LENS WAS CRACKED EXTERNALLY. 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 11964924 ↗MalfunctionMay 29, 2021Crack; Crack
IT WAS REPORTED THAT DURING A KNEE SCOPE, THE VIDEOARTHROSCOPE LENS WAS CRACKED EXTERNALLY, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11905743 ↗MalfunctionMay 25, 2021Crack; Crack
IT WAS REPORTED THAT THE SCOPE LENS WAS CRACKED EXTERNALLY. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11875806 ↗MalfunctionMay 20, 2021Crack; Crack
IT WAS REPORTED THAT THE SCOPE WAS CRACKED DURING SET UP FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO INJURIES, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED DISTAL LENSES WHICH MAKES IT A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11854872 ↗MalfunctionMay 18, 2021Crack; Crack
IT WAS REPORTED THAT, DURING USE, THE SCOPE LENS WAS CRACKED EXTERNALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11845400 ↗MalfunctionMay 14, 2021Crack; Crack
IT WAS REPORTED THAT THE SCOPE WAS CRACKED ON THE TIP OF THE LENS DURING SET UP FOR AN UNSPECIFIED PROCEDURE. THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO PATIENT INJURIES, DELAYS OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11828834 ↗InjuryApr 27, 2021Crack; Crack
IT WAS REPORTED THAT DURING A PROCEDURE, THE LENS OF THE SCOPE (4KO VIDEOARTHROSCOPE AC 4X30X160MM) WERE CRACKED EXTERNALLY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR COMPLICATIONS TO PATIENT REPORTED DUE THIS EVENT. 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 11731725 ↗InjuryApr 27, 2021Crack; Crack
IT WAS REPORTED THAT DURING A PROCEDURE, THE LENS OF THE SCOPE (4KO VIDEOARTHROSCOPE AC 4X30X160MM) WERE CRACKED EXTERNALLY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR COMPLICATIONS TO PATIENT REPORTED DUE THIS EVENT. 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 11731722 ↗MalfunctionApr 8, 2021Crack; Optical Obstruction; Crack; Optical Obstruction
IT WAS REPORTED THAT THE SCOPE LENS WAS CRACKED SO PICTURE WAS BLURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED DISTAL LENS WHICH MAKES IT A REPORTABLE EVENT. 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 11637825 ↗MalfunctionApr 8, 2021Crack; Optical Obstruction; Crack; Optical Obstruction
IT WAS REPORTED THAT THE SCOPE WAS BLURRY. INCIDENT OCCURRED DURING AN INSPECTION, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED DISTAL LENS WHICH MAKES IT A REPORTABLE EVENT. 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 11637791 ↗
Other Arthroscope devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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.
How reports and recalls are matched · Editorial policy · Report an error on this page