NA 4184SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010125569), received between Feb 20, 2019 and May 11, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Crack” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2021Crack; Crack

  IT WAS REPORTED THAT THE PART OF THE IMAGE IN THE SCOPE WAS BLURRY. NO CASE INVOLVED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS DEVICE HAD COMPACT LENS CRACKED WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809629 ↗
• MalfunctionApr 20, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE WAS NOT WORKING. NO PATIENT WAS INVOLVED AS THE EVENT OCCURRED AFTER THE SURGERY. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACKED COMPACT 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 11693809 ↗
• MalfunctionMar 29, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SETUP OF THE PROCEDURE, THE SCOPE HAD A CRACK IN THE TIP LENS. IT IS UNKNOWN WHEN THE EVENT OCCURRED OR IF THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY NOR PATIENT INJURY REPORTED. 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 11586464 ↗
• MalfunctionMar 19, 2021Crack; Crack

  IT WAS REPORTED THAT, THE TIP LENS IN THE "ARTHROSCOPE (1.9MM X 30°)" WAS CRACKED. NO CASE REPORTED; 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 11532008 ↗
• MalfunctionMar 15, 2021Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE ARTHROSCOPE'S LENS WAS FOUND TO BE DAMAGED. NO CASE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CRACK 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 11484025 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT THE ASCOPE DISTAL LENS WAS BROKEN. NO CASE REPORTED; 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 Patient Involvement

  MAUDE report 10667577 ↗
• MalfunctionMay 14, 2020Optical Problem; Optical Problem

  IT WAS REPORTED THAT, THE "1.9 MM X 30° ARTHROSCOPE" HAD THE WHOLE IMAGE CLOUDY. NO CASE REPORTED; 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 Patient Involvement

  MAUDE report 10057753 ↗
• MalfunctionMay 5, 2020Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPY, THE ARTHROSCOPE HAD A BLURRY VIEW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10026245 ↗
• MalfunctionApr 25, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, PART OF THE 1.9MM X 30° ARTHROSCOPE VIEW WAS CLOUDY. NO CASE REPORTED; 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 Patient Involvement

  MAUDE report 9999320 ↗
• MalfunctionFeb 20, 2019Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE DEVICE HAD A DAMAGE OF TIP LENS. THERE WAS NOT ANY BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NEITHER SURGICAL DELAY NOR PATIENT INJURIES HAVE BEEN STATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353983 ↗