NA 72202959SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00885554023367), received between Sep 13, 2017 and Aug 1, 2023 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Crack” (15 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE VIDEO ARTHROSCOPE WAS FOGGING AND NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438095 ↗
• MalfunctionApr 14, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SCOPE HAD A CRACKED LENS. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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

  MAUDE report 11664380 ↗
• MalfunctionMar 26, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  IT WAS REPORTED THAT THERE WAS A RED LINE ON THE SPOT VIEW OF THE SCOPE. NO CASE WAS INVOLVED. 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 11576399 ↗
• MalfunctionMar 24, 2021Crack; Crack

  IT WAS REPORTED THAT DURING USE THE CUSTOMER NOTICED THAT THEIR 30° SCOPE WAS NOT FUNCTIONING CORRECTLY AND A REPAIR WAS NEEDED. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE AND THERE WAS NO 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 11565566 ↗
• MalfunctionMar 18, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SCOPE LENS WERE FOUND TO BE SCRATCHED. 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. 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 11513499 ↗
• MalfunctionMar 11, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE LENS DID NOT FOCUS. NO CASE WAS INVOLVED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD THE DISTAL LENS CRACKED 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 11467383 ↗
• MalfunctionMar 11, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SCOPE WAS FOGGY. 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 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 11463533 ↗
• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A VAS, HD, AC, 4MM X 30 DEG SERVICE EVALUATION IT WAS FOUND THAT THE TIP LENS WAS CRACKED. NO PATIENT WAS INVOLVED BECAUSE THIS WAS FOUND DURING SERVICE AND REPAIR. 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 11448737 ↗
• MalfunctionFeb 24, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE SCOPE WAS BENT. 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 THE DISTAL LENS BORKEN 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 11375010 ↗
• MalfunctionFeb 18, 2021Crack; Optical Obstruction; Crack; Optical Obstruction

  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 HAD HAD DISTAL LENS CRACKED 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 11342897 ↗
• MalfunctionFeb 17, 2021Crack

  IT WAS REPORTED THAT THE TIP LENS OF THE SCOPE WAS 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 11339832 ↗
• MalfunctionJan 13, 2021Crack; Crack

  IT WAS REPORTED THAT DURING SET UP, THE SCOPE LENS TIP WAS CRACKED. 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 11159698 ↗
• MalfunctionDec 23, 2020Corroded; Corroded

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, RUST WAS FOUND ON THE VAS HD AC. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. 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 11069800 ↗
• MalfunctionDec 23, 2020Crack; Crack

  IT WAS REPORTED THAT THE DISTAL END OF THE SCOPE WAS CRACKED. THIS WAS NOTICED DURING SET UP FOR A KNEE SCOPE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066378 ↗
• MalfunctionOct 30, 2020Crack; Crack

  IT WAS REPORTED THAT DURING THE SURGERY THE SCOPE HAD AN EXTERNAL LENS CRACKED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS USED 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 Information

  MAUDE report 10766378 ↗
• MalfunctionOct 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING PROCEDURE, THE SCOPE GOT CRACKED ON THE OUTSIDE LENS. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 10756129 ↗
• MalfunctionOct 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCOPE HAD HOLES IN THE DISTAL TIP AND A DAMAGED DISTAL LIGHT FIBER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10655287 ↗
• MalfunctionOct 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCOPE HAD HOLES IN THE DISTAL END AND A DAMAGED DISTAL LIGHT PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10653090 ↗
• MalfunctionOct 4, 2020Crack; Crack

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCOPE HAD A CRACKED ON THE DISTAL CENTER OF THE LENS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR PATIENT INJURIES 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 10624523 ↗
• MalfunctionSep 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE DISTAL END OF THE LENS WAS FOUND CRACKED OUTSIDE THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND 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 10610109 ↗
• MalfunctionSep 22, 2020Crack; Crack

  IT WAS REPORTED THAT DURING KNEE SCOPE PROCEDURE, THE SCOPE WAS SCRATCHED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAS 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 Information

  MAUDE report 10569711 ↗
• InjurySep 10, 2020Crack; Crack

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE VIDEOARTHROSCOPIC WAS FOUND TO HAVE A CRACKED LENS. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. RESULTS OF INVESTIGATION REVEALED THAT DURING VISUAL EVALUATION THE SCOPE DISTAL LENS WAS CRACKED, 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 Information

  MAUDE report 10513609 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE THE END WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO DELAY OR 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 10451791 ↗
• MalfunctionMay 15, 2020Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT, THE SCOPE IMAGE WAS BLURRY. 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 10063715 ↗
• MalfunctionAug 20, 2018Poor Quality Image

  IT WAS REPORTED THAT THE DEVICE HAS A BLACK IMAGE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796820 ↗