NA 72202961SRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00885554024203), received between Sep 13, 2017 and Jun 8, 2021 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Crack” (13 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE WAS CRACKED. 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 11959161 ↗
• MalfunctionMay 25, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE WAS NOT WORKING. NO CASE WAS INVOLVED. 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 11876336 ↗
• MalfunctionMay 21, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE, THE SCOPE WAS CLOUDY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11864038 ↗
• MalfunctionApr 16, 2021Crack; Crack

  IT WAS REPORTED THAT, THE HD VIDEOARTHROSCOPE HAD A FUZZY PICTURE. 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. 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 11678177 ↗
• MalfunctionApr 9, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, THE SCOPE WAS FOUND SCRATCHED, BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY. NO PATIENT INJURIES 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 11641446 ↗
• MalfunctionMar 31, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  IT WAS REPORTED THAT, THE "HD VIDEOARTHROSCOPE (4MM X 30°)" WAS BLURRY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY 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 11598930 ↗
• MalfunctionMar 31, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT DURING THE SET-UP OF A KNEE ARTHROSCOPY, THE LENS OF THE VIDEO ARTHROSCOPE HD 4MM X 30 DEG WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11594690 ↗
• MalfunctionMar 24, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE VIEW WAS FOGGY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. 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 11565370 ↗
• MalfunctionMar 18, 2021Crack; Poor Quality Image; Crack; Poor Quality Image

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCOPE HAD A BLURRY/FOGGY IMAGE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR PATIENT INJURIES 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 11520757 ↗
• MalfunctionMar 18, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE WAS CRACKED. 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. 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 11513411 ↗
• MalfunctionMar 14, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE WAS CRACKED. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. RESULTS OF INVESTIGATION HAVE SHOWN 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11479045 ↗
• MalfunctionMar 13, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  IT WAS REPORTED THAT THE SCOPE IMAGE WAS NOT CLEAR AND HAD LINES. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478524 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE WAS FOGGY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD THE DISTAL LENS BROKEN 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 11461794 ↗
• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT THE VIDEOARTHROSCOPE WAS FOUND TO HAVE AN UNSPECIFIED FUNCTIONAL FAILURE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD BROKEN LENSES INCLUDING THE 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 11447949 ↗
• MalfunctionFeb 18, 2021Crack; Crack

  IT WAS REPORTED THAT DURING THE SET UP BEFORE A KNEE SCOPE SURGERY THE SCOPE WAS LOOSE. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A CHIPPED DISTAL LENS WITH SCRATCHES ON NEEDLE 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 11343016 ↗
• MalfunctionFeb 15, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  IT WAS REPORTED THAT THE SCOPE'S LENS WERE EXTERNALLY CRACKED AND HAD BLACK DOTS. 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 11329989 ↗
• MalfunctionMay 7, 2020Optical Problem; Optical Problem

  IT WAS REPORTED THAT, THE 4MM X 30° HD VIDEOARTHROSCOPE HAD A BLURRY VIEW. 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 10032444 ↗
• MalfunctionMay 5, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT THE VIDEOARTHROSCOPE HAD A BLURRY PICTURE. NO CASE INVOLVED. 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 10026827 ↗
• MalfunctionNov 26, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCOPE LENS DID NOT ATTACH PROPERLY. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH A DELAY GREATER THAN 30 MINUTES. NO PATIENT INJURIES 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 9376041 ↗
• MalfunctionSep 19, 2019Scratched Material

  IT WAS REPORTED THAT DURING A KNEE SURGERY THERE WAS A SCRATCH ON THE DISTAL TIP OF THE SCOPE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088375 ↗
• MalfunctionSep 19, 2019Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE SCOPE HAD A SCRATCH ON THE DISTAL TIP OF THE LENS. THERE WAS A DELAY GREATER THAN THIRTY MINUTES IN THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086231 ↗
• MalfunctionAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE PROCEDURE, THE DEVICE WAS SCRATCHED. BACK-UP DEVICE WAS NOT AVAILABLE AND IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Information

  MAUDE report 8944169 ↗
• MalfunctionAug 25, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE LENS WAS BLACK. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928787 ↗
• MalfunctionAug 8, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, SPOTS WERE NOTICED ON THE SCOPE LENS CAUSING A COMPLETE LOSS OF VISUALIZATION DURING THE SURGERY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8873326 ↗
• MalfunctionAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SCOPE HAD A BLACK FLOATER DURING A KNEE ARTHROSCOPY. THERE WAS NO DELAY OR PATIENT INJURIES BUT, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED SINCE NO BACKUP DEVICE WAS AVAILABLE TO COMPLETE IT. ATTEMPTS WERE MADE TO RETRIEVE FURTHER INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871938 ↗