NA 72202088SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010645005), received between May 22, 2018 and May 20, 2021 — classified as 1 injury, 11 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT THE SCOPE WAS DAMAGED, NO FURTHER DETAILS. NO CASE 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 11860121 ↗
• MalfunctionMay 13, 2021Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823135 ↗
• MalfunctionMay 7, 2021Crack; Crack

  IT WAS REPORTED THAT DURING THE SURGERY THE SCOPE HAD SCRATCHED LENS. 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 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 11791050 ↗
• MalfunctionApr 14, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE HAD A CRACK IN THE TIP OF LENS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11668414 ↗
• MalfunctionMar 18, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A HIP SCOPE SURGERY THE SCOPE LENS WAS SCRATCHED. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN HOW THE SURGERY WAS COMPLETED. 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 11516219 ↗
• MalfunctionFeb 26, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE HAD THE TIP OF THE LENS CRACKED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11388110 ↗
• InjuryFeb 15, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A HIP SURGERY PROCEDURE, THE TIP/END LENS OF THE SCOPE APPEARED TO BE CRACKED, IT COULD BE SEEN THROUGH THE EYE PIECE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS 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 11330517 ↗
• MalfunctionNov 25, 2020Crack; Crack

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE DISTAL END OF THE "ARTHROSCOPE (4MM X 70°)" HAD A CRACK IN IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 10899912 ↗
• MalfunctionMay 7, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE SCOPE WAS CLOUDY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. 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 10036980 ↗
• MalfunctionMar 28, 2019Connection Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT CONNECTING TO THE CAMERA HEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 31 MIN-1 HOUR. THERE WAS NO BACK-UP DEVICE AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WHERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461173 ↗
• MalfunctionMay 29, 2018Break

  IT WAS REPORTED THAT THE DEVICE HAS A DAMAGED INK. THERE WAS A SURGERY DELAY GREATER THAN 30 MIN. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7551297 ↗
• MalfunctionMay 22, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS GARBAGE INSIDE THE SCOPE. THERE WAS A DELAY OF MORE THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533735 ↗