NEEDLESCOPE 7205682Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010380432), received between Mar 8, 2018 and Mar 10, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Misfocusing; Dent in Material; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Scratched Material

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE ARTHROSCOPE WAS NOT FOCUSING PROPERLY OVERALL AND HAD A SHORT STEM. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558035 ↗
• InjuryMar 9, 2026Optical Problem

  IT WAS REPORTED THAT, BEFORE AN ELBOW ARTHROSCOPY, ONE (1) SCOPE WAS FOUND TO BE DARK, WHICH MADE PROPER VISUALIZATION VIA ARTHROSCOPY IMPOSSIBLE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY; HOWEVER, THE PROCEDURE WAS PERFORMED, WITH A CHANGE IN SURGICAL TECHNIQUE TO AN OPEN PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547273 ↗
• MalfunctionApr 27, 2022Optical Obstruction; Scratched Material; Optical Obstruction; Scratched Material

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE PICTURE ON THE LENS OF AN ARTHROSCOPE WAS FOGGY AND IT HAD A SCRATCH THAT WAS VISIBLE. SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30MINS, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222609 ↗
• MalfunctionMay 31, 2021Break; Break

  IT WAS REPORTED THAT THE TIP LENS OF THE SCOPE WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910716 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SCOPE'S EXTERNAL LENS WAS BROKEN (SCRATCHED/ FRACTURED). 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 11684552 ↗
• MalfunctionApr 15, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE EXTERNAL LENS IN THE ARTHROSCOPE WAS BROKEN. NO CASE REPORTED; THEREFORE THERE WAS NO PATIENT INVOLVED. 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 11675888 ↗
• MalfunctionApr 13, 2021Crack; Crack

  IT WAS REPORTED THAT, THE SCOPE WAS FOUND WITH THE DISTAL TIP OF THE LENS CRACKED/SCRATCHED WHEN THE SALES REP PICKED UP THE TRAY FROM AN ACCOUNT. THE INCIDENT OCCURRED AFTER THE PROCEDURE; 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 11657315 ↗
• MalfunctionApr 12, 2021Crack; Crack

  IT WAS REPORTED THAT THE DISTAL TIP OF SCOPE WAS FOUND CRACKED IN THE STORAGE. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. 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 11653915 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE HAD A BROKEN EXTERNAL LENS. 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 11611267 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE EXTERNAL LENS WAS BROKEN. NO CASE WAS INVOLVED. 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 11610873 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE HAD A BROKEN EXTERNAL LENS. 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 11610863 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE HAD A BROKEN EXTERNAL LENS. 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 11599699 ↗
• MalfunctionAug 26, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE SCOPE WAS BENT, AND NO LIGHT WAS GETTING THROUGH THE CAMERA BECAUSE OF THIS THERE WAS A COMPLETE LOSS OF VISUALIZATION DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8933586 ↗
• MalfunctionMay 3, 2019Fogging

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE SCOPE DID NOT FOCUS AS THE IMAGE WAS FOGGY. AS THERE WAS NOT BACK UP DEVICE AVAILABLE, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8580200 ↗
• MalfunctionNov 16, 2018Material Opacification

  IT WAS REPORTED THAT THE DEVICE LENS IS NOT CLEAR. LOSS OF VISUALIZATION WAS BEFORE THE CASE. THERE WAS NOT SIGNIFICANT DELAY AND NO PATIENT INJURIES. A BACK-UP DEVICE WAS ABLE TO BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8078263 ↗
• MalfunctionMar 8, 2018Poor Quality Image

  IT WAS REPORTED THAT THE IMAGE OF THE DEVICE WAS VERY DARK AND BLURRY, NOT ENOUGH LIGHT WAS COMING THRU THE SCOPE DID NOT MAKE OUT THE INSIDE OF THE PATIENT'S WRIST. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323432 ↗