NA 72202087Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 03596010616869), received between Sep 20, 2017 and Nov 11, 2025 — classified as 8 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A BIOAB SHOULDER INSTABILITY PROCEDURE, ONE (1) ASCOPE ACLAVE HD 4MM X 30 DEG BROKE, LEAVING PART OF IT IN THE ROTATING CANNULA AND THE OTHER PART ATTACHED TO THE CAMERA COUPLER. THE OPTICS REMAINED IN THE ROTATING CANNULA AND WERE THEREFORE NOT LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A ONE-HOUR DELAY, AND DUE TO A LACK OF SPARE EQUIPMENT, THE DOCTOR CHANGE TO AN OPEN PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526714 ↗
• MalfunctionJul 10, 2025Material Integrity Problem; Optical Distortion; Material Integrity Problem; Optical Distortion

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LENS OF THE ARTHROSCOPE WAS BROKEN (WITH FRAGMENTATION) AND IT HAD A BLURRED IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465706 ↗
• InjuryJun 9, 2025Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT DURING AN SHOULDER ROTATOR CUFF PROCEDURE, THE ARTHROSCOPE HAD AN INFILTRATION OF THE OPTICS, MAKING IT IMPOSSIBLE TO CONTINUE THE SURGERY VIA ARTHROSCOPIC SURGERY. THE INTERVENTION THEN CONTINUED, VIA AN OPEN APPROACH TO REPAIR THE ROTATOR CUFF. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166790 ↗
• InjuryNov 6, 2023Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING THE CUFF SUTURING PROCEDURE, WHEN THE ARTHROSCOPE WAS BEING ASSEMBLED, IT WAS NOTICED THE OPTICS WERE FOGGED. THE SURGEON DECIDED TO PERFORM AN OPEN SURGERY INSTEAD, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080464 ↗
• InjuryOct 3, 2023Moisture or Humidity Problem; Scratched Material; Moisture or Humidity Problem; Scratched Material

  IT WAS REPORTED THAT DURING SET-UP FOR A SHOULDER SCOPE, IT WAS NOTICED THAT AN ARTHROSCOPE´S OPTICS WERE SCRATCHED; WHICH WAS COMMUNICATED TO THE NURSE; HOWEVER THE PHYSICIAN STARTED THE SURGERY AND AT THE END THERE WAS INFILTRATION IN THE OPTICS. SURGERY HAD TO BE COMPLETED OPEN WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862697 ↗
• MalfunctionJun 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCOPE HAD THE LENS WORN AND DAMAGED, RESULTING IN THE INABILITY TO DISPLAY THE VIEWING ANGLE AREA OF THE LENS NORMALLY, SERIOUSLY AFFECTING THE SURGERY AND CAUSING A DELAY. THE PROCEDURE WAS CANCELLED STRAIGHT AWAY AND A NEW SURGERY WAS SCHEDULE.

  Patient problems: Insufficient Information

  MAUDE report 17199728 ↗
• MalfunctionJun 2, 2023Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SCOPE DEVICE HAD A BLURRED VISION. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED, A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051022 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE OPTICS OF THE SCOPE BROKE, RELEASING THE BLACK PART OF THE METALLIC TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279575 ↗
• InjuryMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE OPTICS OF THE SCOPE BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SURGICAL TECHNIQUE, (OPENED THE KNEE AND USED OLD TECHNIQUES). NO DELAY NOR PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847377 ↗
• MalfunctionMar 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS EVIDENT THAT THE AUTOCLAVABLE SCOPE WAS INFILTRATED AND IT WAS IMPOSSIBLE TO VIEW. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13754164 ↗
• MalfunctionJul 22, 2021Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, WHEN THE SCOPE WAS ATTACHED TO THE CAMERA HEAD, THE FIELD OF VIEW WAS SO BLURRY THAT COULD NOT ACCURATELY MAKE OUT THE STRUCTURES WITHIN THE KNEE. DUE TO A NUMBER OF ISSUES WITH EQUIPMENT LEADING UP TO THIS POINT, AFTER THIS FAULT WAS FOUND THE CASE WAS ABANDONED TO AVOID CAUSING HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213710 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS A CLUCK AT THE SCOPE TIP. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801108 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE WAS NOT FUNCTIONALLY, THE EXTERNAL LENS WAS 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 11757258 ↗
• MalfunctionApr 27, 2021Crack; Crack

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON THE DISTAL TIP OF THE SCOPE. 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 11732215 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT DURING HEADDRESS REPAIR SURGERY, THE LENS AT THE END OF THE OPTIC IN THE ARTHROSCOPE 30-DEGREE AUTOCLAVABLE WAS CRACKED AND PROVIDED A BLACK IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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 11723287 ↗
• MalfunctionApr 19, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SCOPE'S EXTERNAL LENS WAS BROKEN (SCRATCH/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 11684739 ↗
• MalfunctionApr 19, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SCOPE'S EXTERNAL LENS WAS NOT FUNCTIONALLY, THE EXTERNAL LENS WAS 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 11684587 ↗
• MalfunctionApr 16, 2021Crack; Crack

  IT WAS REPORTED THAT, THE "HD ARTHROSCOPE (4MM X 30°)" SHOWED A HALO AROUND THE 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 11678962 ↗
• MalfunctionApr 14, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE EXTERNAL LENS COVER WAS FOUND TO BE BROKEN. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11663441 ↗
• MalfunctionMar 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE ASCOPE ACLAVE HD 4MM X 30 DEG TIP LENS 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 11536657 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THERE WAS A BROKEN METAL PIECE HANGING OFF FROM THE TIP OF THE SCOPE. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 10942902 ↗
• InjuryDec 3, 2020Crack; Crack

  IT WAS REPORTED THAT, DURING SURGERY, THE DISTAL END OF THE "HD ARTHROSCOPE (4MM X 30°)" WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10942703 ↗
• MalfunctionNov 17, 2020Crack; Crack

  IT WAS REPORTED THAT THE SCOPE WAS BLURRY AND THERE WAS A CRACK IN THE DISTAL TIP OF THE SCOPE. 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 10852294 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL LENS IN THE SCOPE WAS BROKEN. 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 10835934 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL LENS IN THE SCOPE WAS BROKEN. 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 10835385 ↗