4KO 72205154Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556736074), received between Apr 6, 2021 and Dec 29, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Optical Distortion” (5 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DEMO PROCEDURE, THE SCOPE LENS WAS DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH & NEPHEW SIMILAR DEVICE WITH A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908269 ↗
• InjuryNov 24, 2025Misfocusing; Misfocusing

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY PROCEDURE, AN ARTHROSCOPE WAS NOT FOCUSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, THE DOCTOR DECIDED TO PROCEED WITH THE SURGERY WITHOUT THE ARTHROSCOPY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630745 ↗
• MalfunctionSep 9, 2025Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ARTHROSCOPE WAS GIVING A FOGGY IMAGE. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007355 ↗
• MalfunctionSep 9, 2025Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE ARTHROSCOPE DISPLAYED A FOGGY IMAGE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006620 ↗
• MalfunctionMay 19, 2025Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ARTHROSCOPE WAS BLURRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047956 ↗
• MalfunctionMay 14, 2025Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROSCOPE'S IMAGE WAS FOGGY. THE PROCEDURE WAS COMPLETED USING A BACK-UP 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 22019078 ↗
• MalfunctionApr 1, 2025Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SCOPE HAD A FOGGING ISSUE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748943 ↗
• MalfunctionMar 6, 2025Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, SUDDENLY THE SCOPE WAS BLURRY ON THE SIDE. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540244 ↗
• MalfunctionJan 27, 2025Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT, DURING SURGERY, THE ARTHROSCOPE DISPLAYED A SHADOW IMAGE WITH BLURRED FOCUS. 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 21248802 ↗
• MalfunctionDec 30, 2024Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROSCOPE VISION WAS NOT CLEAR. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039615 ↗
• MalfunctionSep 7, 2023Crack; Crack

  IT WAS REPORTED THAT DURING SET UP FOR A MENISCAL REPAIR SURGERY, THE LENS OF THE ARTHROSCOPE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SIGNIFICANT SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703653 ↗
• MalfunctionMay 18, 2021Crack; Crack

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE DISTAL TIP OF THE SCOPE WAS CRACKED. THERE WAS A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846484 ↗
• MalfunctionApr 6, 2021Crack; Crack

  IT WAS REPORTED THAT, BEFORE A SHOULDER ARTHROSCOPY, THE SCOPE WAS SCRATCHED. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO 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 11618808 ↗