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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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Sources and updates

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