NA 72202088Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010616876), received between Apr 2, 2018 and Nov 28, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2024Break; Break

  IT WAS REPORTED DURING A HIP ARTHROSCOPY, THE DOCTOR ACCIDENTALLY HIT ARTHROSCOPE OPTICAL WITH ANOTHER TWEEZER BREAKING IT, AND NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805693 ↗
• MalfunctionApr 19, 2021Crack; Crack

  IT WAS REPORTED THAT, THE "HD ARTHROSCOPE (4MM X 70°)" WAS BLURRY. 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 11684772 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE HAD A BROKEN EXTERNAL LENS, THAT'S ALL THE INFORMATION PROVIDED. 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 11611275 ↗
• MalfunctionMar 30, 2021Crack; Poor Quality Image; Material Deformation; Crack; Poor Quality Image; Material Deformation

  IT WAS REPORTED THAT THE A SCOPE ACLAVE HD WAS SCRATCHED/BLURRY. THERE WAS NO HOSPITAL INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT EITHER. PRELIMINARY 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 11588471 ↗
• MalfunctionOct 20, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SET UP THE SCOPE WAS COMPLETELY BLACK AND WILL NOT PROVIDE ANY VIEW. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND A DELAY GREATER THAN 30 MINUTES WAS 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; No Known Impact Or Consequence To Patient

  MAUDE report 10706133 ↗
• MalfunctionOct 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE SET UP BEFORE A HIP SCOPE, THE SCOPE HAD AN UNSPECIFIED FUNCTIONAL FAILURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA. ANOTHER SMITH AND NEPHEW BACK-UP DEVICE WITH A DIFFERENT PART NUMBER WAS USED TO COMPLETE THE SURGERY. NO 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 Information

  MAUDE report 10702885 ↗
• MalfunctionOct 20, 2020Crack; Poor Quality Image; Optical Obstruction; Crack; Poor Quality Image; Optical Obstruction

  IT WAS REPORTED THAT DURING THE SET UP BEFORE A HIP SCOPE, THE SCOPE HAD A CRACK AND THE VISION WAS BLURRY. A DELAY GREATER THAN 30 MINUTES WAS REPORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA. ANOTHER SMITH AND NEPHEW BACK-UP DEVICE WITH A DIFFERENT PART NUMBER WAS USED TO COMPLETE THE SURGERY. NO 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; No Patient Involvement

  MAUDE report 10702872 ↗
• MalfunctionOct 18, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL LENS WERE CRACKED AND LIGHT FIBERS DAMAGED. THE MALFUNCTION HAPPENED DURING SET UP FOR AN ARTHROSCOPY 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 Patient Involvement

  MAUDE report 10694807 ↗
• InjurySep 3, 2020Crack; Crack

  IT WAS REPORTED THAT THE SURGEON FORCEFULLY INSERTED THE SCOPE/CANNULA VIA SLOTTED CANNULA AS A GUIDE. THERE WAS A SLIGHT INTERNAL CRACK OF DISTAL SCOPE LENS. LIKELY, DUE TO THE AMOUNT OF PRESSURE THE SLOTTED CANNULA PLACED ON THE SCOPE LENS. THE MALFUNCTION WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES WITH NO PATIENT HARM USING A BACK UP DEVICE AND NO FRAGMENTS REMAIN IN JOINTS. 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 10491718 ↗
• MalfunctionJan 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE LEFT JOINT KNEE, SYNOVECTOMY, JOINT CAVITY CLEANING, USE OPPOSITE GRACILIS FEMORIS AND SEMITENDINOSUS TENDON TO REPAIR AND RECONSTRUCT THE ANTERIOR CRUCIATE LIGAMENT, SUTURE OF THE LATERAL MENISCUS AND SUTURE OF THE MEDIAL COLLATERAL LIGAMENT OF THE LEFT KNEE WERE PERFORMED. AFTER SURGERY, X-RAY EXAMINATION WAS PERFORMED AND SHOWED THERE WERE SUSPICIOUS METAL FOREIGN BODIES IN THE LEFT KNEE AND PATIENT SWELLING ABOUT LEFT KNEE. 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 9545991 ↗
• MalfunctionJul 28, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS DARK SCREEN INDICATING A CRACK IN THE SCOPE. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834818 ↗
• MalfunctionJan 16, 2019Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MECHANICAL BURR NICKED THE TIP OF THE SCOPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND THERE WAS NO BACK-UP AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253515 ↗
• MalfunctionApr 2, 2018Device Inoperable

  IT WAS REPORTED THAT THE SCOPE STOPPED WORKING DURING A PROCEDURE AND IT IS UNKNOWN IF THERE WAS A LOSS OF IMAGE OR VISUALIZATION DURING THE SURGICAL PROCEDURE. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390790 ↗