NA 72202087SRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 03596010644534), received between Mar 6, 2018 and Oct 4, 2022 — classified as 2 injuries, 42 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. 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE ARTHROSCOPE HAD PICTURE ISSUES. 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 15535516 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT THE ASCOPE HAD THE LENS TIP BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965574 ↗
• MalfunctionJun 7, 2021Crack; Crack

  IT WAS REPORTED THAT THE ARTHROSCOPE WAS FOUND TO HAVE DAMAGE TO THE NEGATIVE LENS. NO CASE REPORTED. 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 11947694 ↗
• MalfunctionMay 26, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCREEN OF THE SCOPE WAS BLURRY. 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 11891566 ↗
• MalfunctionMay 20, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE THE ASCOPE A/C HD WAS CRACKED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859970 ↗
• MalfunctionMay 14, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE HAD CRACKED TIP LENS. NO ADDITIONAL INFORMATION IS AVAILABLE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829004 ↗
• MalfunctionMay 5, 2021Crack; Crack

  IT WAS REPORTED THAT, THE SCOPE'S TIP 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 11781382 ↗
• MalfunctionApr 20, 2021Crack; Crack

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION FOR AN ACL PROCEDURE, THE SCOPE LENS WAS CRACKED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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 11693778 ↗
• MalfunctionApr 20, 2021Crack; Poor Quality Image; Crack; Poor Quality Image

  IT WAS REPORTED THAT, DURING USE, THE ASCOPE ACLAVE HD 4MM X 30 DEG IMAGE WAS BLURRY. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY NOR PATIENT INJURY. 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 11693764 ↗
• MalfunctionApr 19, 2021Crack; No Display/Image; Crack; No Display/Image

  IT WAS REPORTED THAT THE SCOPE (ASCOPE A/C HD 30 DEG 4MM) HAS THE TIP LENS CRACKED. IMAGE IS NOT DISPLAYED. NO CASE REPORTED; THEREFORE, NO PATIENT WAS 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 11691475 ↗
• MalfunctionMar 28, 2021Crack; Crack

  IT WAS REPORTED THAT, THE SCOPE HAD CRACKS IN THE TIP LENS. 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 11580540 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE LENS TIP 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11529981 ↗
• MalfunctionMar 16, 2021Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE ASCOPE A/C HD 30 DEG 4MM HAD A DEFECTIVE OPTIC, CLOUDY AND THE LENS WERE BROKEN. A 70 DEGREE SMITH AND NEPHEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. 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 11499384 ↗
• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE WAS DOWN DUE TO CLOUDING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A BROKEN 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 11448569 ↗
• MalfunctionMar 9, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE PRESENTED AN UNKNOWN MALFUNCTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A DISTAL LENS IS 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 11447330 ↗
• InjuryFeb 16, 2021Break; Break

  IT WAS REPORTED THAT THE ASCOPE A/C HD BROKE WHILE IN USE IN A SHOULDER SURGERY, THE BROKEN PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY 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 11335612 ↗
• MalfunctionFeb 15, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE DISTAL LENS 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 11330041 ↗
• MalfunctionFeb 15, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE DISTAL TIP WAS BURRED, IT HAS A ROUGH EDGES. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY. NO 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 11330019 ↗
• MalfunctionFeb 15, 2021Crack; Crack

  IT WAS REPORTED THAT THE SCOPE DISTAL LENS 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 11329996 ↗
• MalfunctionJan 30, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE HAD THE DISTAL LENS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11256293 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL LENS ARE BROKEN. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT 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 10943033 ↗
• MalfunctionNov 5, 2020Crack; Crack

  IT WAS REPORTED THAT THE ARTHROSCOPE'S DISTAL LENS WAS FOUND TO BE CRACKED. NO CASE REPORTED. 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 10796371 ↗
• MalfunctionOct 25, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCOPE PRESENTED NO IMAGE, JUST BLACK. 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 Information

  MAUDE report 10732221 ↗
• MalfunctionOct 22, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS NOT AUTOCLAVE STAMP. 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 10722040 ↗
• InjuryOct 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE SCOPE WAS NOT WORKING. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. IT IS UNKNOWN IF A DELAY HAPPENED IN THE PROCEDURE. HOWEVER, NO 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 10680411 ↗