NA 72200561Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 03596010591104), received between Oct 11, 2017 and Mar 1, 2024 — classified as 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (32 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A CAMERA HEAD STOPPED WORKING. SURGERY RESUMED AFTER A GREATER DELAY OF 1 HOUR WITH THE FACILITY´S EQUIPMENT. SUCCESSFULLY. THERE WAS NO DAMAGE TO THE PATIENT´S HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818436 ↗
• MalfunctionAug 28, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD NON-AC WAS GETTING HOT TO THE TOUCH. THIS HAPPENED BEFORE USE IN PATIENT. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381297 ↗
• MalfunctionJul 20, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE CAMERA HEAD NON-AC HD560H OVERHEATED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197807 ↗
• MalfunctionJul 20, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE CAMERA HEAD WAS OVERHEATING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195818 ↗
• MalfunctionJul 7, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT BEFORE PROCEDURE THE CAMERA HEAD NON-AC HD560H HAS NO IMAGE. NO SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129827 ↗
• MalfunctionJun 23, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD NON-AC HD560H HAD NO IMAGE. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048720 ↗
• MalfunctionJun 21, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD 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 12037282 ↗
• MalfunctionJun 11, 2021No Display/Image; No Display/Image

  IT WAS REPORTED, THAT DURING INSPECTION, THE CAMERA HEAD WAS CONNECTED TO CONTROL UNIT BUT THERE WAS NO SIGNAL AND NO PICTURE. NO PATIENT WERE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986365 ↗
• MalfunctionApr 30, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE CAMERA CONTROL UNIT'S SCREEN HAD NO DISPLAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11757988 ↗
• MalfunctionApr 23, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD PICTURE WAS NOT APPEARING. NO DELAY WAS REPORTED, BACKUP DEVICE WAS AVAILABLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11713295 ↗
• MalfunctionApr 20, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE CAMERA HEAD DISPLAYED A BLANK IMAGE ON MONITOR WHEN IT WAS ON. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED. IT IS UNKNOWN IF EVENT OCCURRED DURING SURGERY OR WHAT PROCEDURE WAS BEING PERFORMED. NO PATIENT INJURY WAS 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 11698463 ↗
• MalfunctionApr 15, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT GENERATING IMAGES. 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 11672339 ↗
• MalfunctionApr 15, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING TESTING, THE CAMERA HEAD'S IMAGE WAS FLICKERING. 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 11670992 ↗
• MalfunctionApr 14, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING ACL SHOULDER PROCEDURE, OUTSIDE THE PATIENT, THE CAMERA HEAD NON-AC HD560H WAS PRODUCING FLICKERING ISSUE IN THE MONITOR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT 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 11665934 ↗
• MalfunctionApr 12, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS NOT LIGHT ON THE CAMERA HEAD. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED. 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 11654239 ↗
• MalfunctionMar 28, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE THE CAMERA HEAD NON-AC HD560H DEVICE NO DISPLAY PICTURE ON THE MONITOR, WHEN THE UNIT IS PLUGGED, INTO THE CAMERA CONTROL UNIT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINS. PATIENT INJURIES WERE NOT 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 11580356 ↗
• MalfunctionMar 27, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE "HD-560H CAMERA HEAD" WAS FLICKERING IN THE MONITOR WHILE OPERATING THE QUANTUM 2 MACHINE. 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 11580122 ↗
• MalfunctionMar 16, 2021Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE CAMERA HEAD WAS FLICKERING IN THE MONITOR. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11495896 ↗
• MalfunctionMar 15, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD IMAGE DID NOT APPEAR IN THE MONITOR. THE INCIDENT OCCURRED DURING ROUTINE INSPECTION. 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 11489786 ↗
• MalfunctionFeb 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE IMAGE IS DISCONNECTED EVERY TIME THE CABLE IS MOVED FROM THE CAMERA SIDE. SUSPECTING DAMAGED CABLE OR LOOSE CONTACT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11388228 ↗
• MalfunctionFeb 26, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD IMAGE WAS BLACK. 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 11388015 ↗
• MalfunctionFeb 18, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT BEFORE A RECONSTRUCTION OF CRUCIATE LIGAMENT SURGERY, THE SCREEN OF THE CAMERA HEAD WAS FOUND BLACK AFTER IT WAS CONNECTED TO THE HOST. NO PATIENT INJURIES OR DELAY WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11346923 ↗
• MalfunctionFeb 18, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT DISPLAYING IMAGE ON THE SCREEN. 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 11343378 ↗
• MalfunctionFeb 15, 2021Electrical /Electronic Property Problem; Connection Problem; Intermittent Energy Output; Electrical /Electronic Property Problem; Connection Problem; Intermittent Energy Output

  IT WAS REPORTED THAT THE CABLE OF THE CAMERA HEAD HAD PROBLEM (POOR ELECTRICAL CONTACT). NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE HAD FLICKERING VIDEO OUTPUT AND THIS IS 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 11329830 ↗
• MalfunctionFeb 13, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, THE IMAGE IN "560 HD CAMERA HEAD" WAS FLICKERING. THERE IS NO INFORMATION REGARDING THE PROCEDURE THAT WAS PERFORMED NOR WHEN THE EVENT OCCURRED. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, THERE WAS NO DELAY OR PATIENT COMPLICATIONS 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 11325925 ↗