NA 72202959Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00885554018783), received between Feb 13, 2018 and Jul 26, 2023 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROSCOPE HAD DAMAGED THE TIP METAL AREA. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER 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 17397770 ↗
• MalfunctionApr 15, 2021Crack; Crack

  IT WAS REPORTED THAT THE DISTAL LENS OF THE SCOPE WAS 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 11669476 ↗
• InjuryMar 24, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A PROCEDURE THE LENS OF THE SCOPE WAS CRACKED. THIS OCCURRED WITH THE INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR PATIENT INJURIES REPORTED. 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 11563515 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VIDEOARTHROSCOPE WAS FOUND TO HAVE PROBLEMS WITH THE FOCUS KNOB, BRIGHTNESS AND BLURRY IMAGE. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A 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 11507047 ↗
• InjuryMar 3, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A HIP CASE THE EXTERNAL LENS OF THE SCOPE CRACKED. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. 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 11408412 ↗
• MalfunctionNov 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCOPE HAD THE DISTAL 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 Patient Involvement

  MAUDE report 10869915 ↗
• MalfunctionOct 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCOPE STEM WAS DENTED AND THE DISTAL END WAS 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 Patient Involvement

  MAUDE report 10653144 ↗
• InjuryOct 3, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCOPE HAD A CRACKED LENS ON THE DISTAL END. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS 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 10624339 ↗
• MalfunctionOct 3, 2020Break; Break

  IT WAS REPORTED THAT SCOPE HAD HOLES ON THE DISTAL END. 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 10624320 ↗
• MalfunctionMay 15, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE SCOPE WAS BLURRY. IT IS UNKNOWN IF THERE WAS A DELAY AND A BACK-UP DEVICE AVAILABLE. 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 10060156 ↗
• MalfunctionMay 14, 2020Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE "4MM X 30° HD VIDEO ARTHROSCOPE" DID NOT HAVE A CLEAR IMAGE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10060038 ↗
• MalfunctionSep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DEVICE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO PATIENT INJURY REPORTED. A DELAY GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9000694 ↗
• MalfunctionSep 3, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING SURGERY WHEN THE DOCTOR WENT TO LOOK IN IT, THERE WAS A CRACKED. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE DISPLAY WAS COMPLETELY LOST WHILE INSIDE THE PATIENT, HOWEVER, THERE WERE NO OTHER TOOLS INSIDE THE PATIENT WHEN IT HAPPENED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Information

  MAUDE report 8957789 ↗
• MalfunctionAug 6, 2019Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING THE KNEE PROCEDURE THE SCOPE WAS FOUND TO BE SCRATCHED. NO DELAY AND NO BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863929 ↗
• MalfunctionMay 9, 2019Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCOPE WAS UNABLE TO FOCUS, CAUSING A COMPLETE LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8594806 ↗
• MalfunctionApr 12, 2019Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS BENT AND THEY CAN'T SEE THROUGH IT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8511289 ↗
• MalfunctionMar 21, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE DEVICE WAS HARD TO ROTATE. NO PATIENT INJURIES OR DELAY REPORTED, THE PROCEDURE WAS FINISH SUCCESSFULLY WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439475 ↗
• MalfunctionDec 1, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WAS NOT POSSIBLE TO SEE THROUGH DEVICE, UNABLE TO GET FOCUS. THERE WAS NOT DELAY IN CASE AND BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121819 ↗
• MalfunctionNov 22, 2018Poor Quality Image

  IT WAS REPORTED A HAZY IMAGE ON THE DEVICE. NO PATIENT INJURY REPORTED. BACK-UP DEVICE WAS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8098945 ↗
• MalfunctionMay 29, 2018Material Discolored

  IT WAS REPORTED THAT DEVICE WAS FOGGY. THE EVENT OCCURED DURING THE PROCEDURE WHILE SURGEON WAS IN THE JOINT SCOPING AND NO BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7550032 ↗
• MalfunctionMay 21, 2018Material Opacification

  IT WAS REPORTED THAT IT CAN'T SEE THROUGH THE DEVICE. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529451 ↗
• MalfunctionFeb 16, 2018No Display/Image

  IT WAS REPORTED THAT THE IMAGE WENT BLACK AND COULDN'T SEE OUT OF IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7276829 ↗
• MalfunctionFeb 13, 2018Scratched Material

  IT WAS REPORTED THAT THE DEVICE WAS SCRATCHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7266502 ↗