NA 72201919Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 03596010643094), received between Nov 24, 2017 and Nov 22, 2024 — classified as 2 injuries, 77 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (28 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Display or Visual Feedback Problem; Overheating of Device; Display or Visual Feedback Problem; Overheating of Device

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE WITH MENISCUS SUTURE, THE CAMERA CONTROL UNIT WAS OVERHEATING, AND THE IMAGE LOSS SHARPNESS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758471 ↗
• MalfunctionNov 21, 2024Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED THAT DURING A KNEE JOINT RESECTION SURGERY, A BLACK SCREEN APPEARED ON THE CAMERA HEAD DISPLAY, AND THE SCREEN KEPT SHAKING, SHOWING AN ERRATIC DISPLAY. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747419 ↗
• MalfunctionOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE CAMERA HEAD FAILED. THE PROCEDURE HAD TO BE CANCELLED DUE TO THE FAILURE REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS SCHEDULED FOR ANOTHER TIME. NO DAMAGE CAUSED; THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 20575528 ↗
• MalfunctionOct 15, 2024Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT, DURING SURGERY, THE CAMERA CONTROL UNIT'S IMAGE WAS RED AND BLUE. SURGERY WAS COMPLETED WITH THE SAME DEVICE, BY HOLDING THE CONNECTION. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452061 ↗
• InjuryApr 30, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA CONTROL UNIT DID NOT RECOGNIZE THE CAMERA HEAD, AND THE MONITOR DID NOT CHANGE FROM COLOR BAR. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND THE SURGERY WAS CANCELED, IT WAS RESCHEDULED FOR A LATER DATE, AND THE PATIENT UNDERWENT TO A REVISION SURGERY ON (B)(6). THE PROCEDURE WAS COMPLETED AND NOTHING FURTHER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214330 ↗
• MalfunctionMar 14, 2024Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA CONTROL UNIT WAS WORKING INTERMITTENTLY WHEN COAGULATING. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909547 ↗
• MalfunctionDec 11, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFFS AND LIGAMENTS ARTHROSCOPY, THE IMAGE ON A CAMERA HEAD WAS INTERMITTENT; THEREFORE, IT WAS CHANGED FOR ANOTHER ONE, BUT THE SAME FAILURE REMAINED; THEN THEY TESTED IT WITH A THIRD CAMERA HEAD, AND IT DISPLAYED A SCREEN OF ONLY ONE COLOR WITHOUT IMAGE. FOR THAT REASON, THEY CONCLUDED THAT THE IMAGE ISSUE WAS WITH THE CAMERA CONTROL UNIT. THE PROCEDURE WAS COMPLETED USING AN S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306821 ↗
• MalfunctionNov 9, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE CAMERA CONTROL UNIT OVERHEATED, CAUSING THE SYSTEM TO CRASH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107540 ↗
• MalfunctionOct 9, 2023Erratic or Intermittent Display; Optical Discoloration; Erratic or Intermittent Display; Optical Discoloration

  IT WAS REPORTED THAT, DURING A GENERAL ARTHROSCOPY, THE CABLE OF THE CAMERA CONTROL UNIT WAS FAULTY, THERE WAS FLASHING AND THE SCREEN WAS GREEN. SURGERY WAS COMPLETED AFTER A SIGNIFICANT SURGICAL DELAY (>31 MINUTES) BY REPLACING THE CABLE OF THE SAME UNIT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17900615 ↗
• MalfunctionMay 29, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING PREOPERATIVE INSPECTION, IT WAS NOTICED THAT SMOKE CAME OUT OF THE CAMERA CONTROL UNIT. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017256 ↗
• MalfunctionOct 26, 2022Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A CAMERA CONTROL UNIT HAD A FOGGY IMAGE ISSUE. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677387 ↗
• MalfunctionJul 10, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT CAMERA CONTROL UNIT OVERHEATED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973921 ↗
• MalfunctionOct 18, 2021Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CAMERA CONTROL UNIT'S SCREEN DID NOT SHOW THE NORMAL COLOR OF THE ABDOMINAL CAVITY WHICH WAS RED AND DARK. THE PATIENT'S GALLBLADDER HAD SEVERE ADHESION WHICH AFFECTED THE RESOLUTION OF THE ANATOMICAL STRUCTURE OF THE GALLBLADDER. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY (31-60 MINUTES) USING A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651445 ↗
• MalfunctionOct 18, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING ENDOSCOPIC EAR SURGERY, OUTSIDE THE PATIENT, THE CAMERA HEAD HAD A PROBLEM WITH THE MONITOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30MIN USING A COMPETITOR DEVICE(SPIES CAMERA). NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650436 ↗
• MalfunctionSep 20, 2021Smoking; Smoking

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT WAS NOT WORKING, WHEN THE UNIT WAS STARTED SMOKE WAS COMING OUT OF IT. THERE WAS NO DELAY REPORTED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502136 ↗
• MalfunctionJul 29, 2021Smoking; Smoking

  IT WAS REPORTED THAT, DURING SET UP OF A KNEE PROCEDURE, WHITE SMOKE CAME OUT FROM THE COOLING HOLE AFTER THE CAMERA CONTROL UNIT WAS TURNED ON. ALTHOUGH NO DELAY WAS REPORTED, IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249310 ↗
• MalfunctionJul 8, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT HAD NO IMAGE ON THE SCREEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12138523 ↗
• MalfunctionJul 1, 2021Smoking; Smoking

  IT WAS REPORTED THAT, DURING A ACL SURGERY, THE CAMERA CONTROL UNIT HAD THICK SMOKE COMING OUT OF IT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104938 ↗
• MalfunctionJun 29, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SURGERY THE CAMERA CONTROL UNIT WHEN PLUGGED IN, THE IMAGE WAS FLICKERING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083455 ↗
• MalfunctionJun 28, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING ROUTINE INSPECTION, WHEN CONNECTING THE "CAMERA CONTROL UNIT, HD 560P"; IT DISTORTED LINES LIKE APPEAR IN THE MONITOR. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079950 ↗
• MalfunctionJun 21, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT HAD A FLICKERING IMAGE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS BACKUP DEVICE AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036981 ↗
• MalfunctionJun 17, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE IMAGE ON THE CAMERA CONTROL UNIT WAS FLICKERING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015805 ↗
• MalfunctionApr 7, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT OVERHEATED. 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 11626963 ↗
• MalfunctionApr 5, 2021Poor Quality Image; Overheating of Device; Smoking; Poor Quality Image; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THERE WAS SMOKE COMING OUT OF THE CAMERA CONTROL UNIT AND IT WAS GETTING HOT. THE IMAGE WAS FLASHING. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11614626 ↗
• MalfunctionMar 18, 2021Erratic or Intermittent Display; Connection Problem; Erratic or Intermittent Display; Connection Problem

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT HIGH DEF 560P HAD A SOCKET PROBLEM AND THERE WAS FLICKERING FIND ON THE MONITOR. 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 11513634 ↗