NA 72202962SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885554024210), received between Apr 11, 2017 and May 18, 2021 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 18, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE LENS WAS SCRATCHED. NO CASE REPORTED; 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841353 ↗
• MalfunctionMay 17, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, OUTSIDE THE PATIENT, THE VIDEOARTHORSCOPE HD 4MM X 70 DEG WAS CRACKED IN THE EXTERNAL LENS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838215 ↗
• MalfunctionMay 11, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE'S DISTAL LENS WAS CRACKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809698 ↗
• MalfunctionApr 6, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY THE SCOPE IMAGE WAS OCCLUDED. 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 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 11619458 ↗
• InjuryApr 5, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE EXTERNAL LENS OF SCOPE WAS CRACKED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11614001 ↗
• MalfunctionMar 3, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE'S EXTERNAL LENS WERE CRACKED IN A HIP CASE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11405480 ↗
• MalfunctionMar 1, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY THE SCOPE IMAGE WAS OCCLUDED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAVE 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 11392826 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT THE LENS AT THE TIP WERE CRACKED. THE MALFUNCTION HAPPENED DURING USE AND WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11263935 ↗
• MalfunctionOct 17, 2020Crack; Crack

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE SCOPE WAS SCRATCHED. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE SCOPE 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 Known Impact Or Consequence To Patient

  MAUDE report 10694675 ↗
• MalfunctionMay 7, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT SCOPE WAS BLURRY. 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 10034693 ↗
• MalfunctionAug 26, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE LENS WAS BLACK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8929770 ↗
• MalfunctionMar 6, 2019Optical Obstruction

  IT WAS REPORTED THAT DURING A RIGHT HIP SCOPE SURGERY, LABRAL REPAIR THEY CAN'T SEE THROUGH THE SCOPE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396548 ↗
• MalfunctionMar 5, 2019Break

  IT WAS REPORTED THAT SCOPE WAS SHATTERED AT THE TIP. NO PATIENT INJURIES OR DELAY WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THE DEVICE BROKE OFF INSIDE THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391843 ↗
• MalfunctionMar 4, 2019Scratched Material

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY, THE CUSTOMER NOTICED THE DISTAL TIP OF THE SCOPE SCRATCHED. THE PROCEDURE DELAYED MORE THAN 30 MINUTES AND IT IS UNKNOWN IF BACK-UP WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8388467 ↗
• MalfunctionMar 19, 2018Device Inoperable

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY, NO BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7348392 ↗
• MalfunctionApr 11, 2017No Display/Image

  IT WAS REPORTED THE VIDEOARTHORSCOPE HD 4MM X 70 DEG WAS ALL BLACK AND WAS UNABLE TO SEE THROUGH IT. THIS OCCURRED DURING THE SURGERY. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO DELAYS OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6483462 ↗