NA 72200561SRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 03596010606808), received between Jul 13, 2017 and Apr 28, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (16 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS OVERHEATING SIGNIFICANTLY. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024044 ↗
• MalfunctionOct 5, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE CAMERA HEAD WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546942 ↗
• MalfunctionJul 21, 2021Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS GETTING HOT WHILE PLUGGED IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12206862 ↗
• MalfunctionJul 1, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE IMAGE ON THE CAMERA HEAD WOULD NOT APPEAR. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099133 ↗
• MalfunctionJun 23, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE SEEN IN THE CAMERA HEAD'S FIELD OF VIEW. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD NO VISIBLE IMAGE WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055459 ↗
• MalfunctionJun 11, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD NOISY IMAGES. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD NO IMAGE WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982387 ↗
• MalfunctionApr 14, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT CAMERA HEAD HAD A CABLE PROBLEM, POOR ELECTRICAL CONTACT DURING SET UP FOR AN UNKNOWN PROCEDURE. IT IS UNKNOWN WHEN IT HAPPENED RELATIVE TO SURGERY. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAIL ALE OR HOW THE ISSUE WAS RESOLVED. IT IS UNKNOWNS IF THERE A DELAY. NO 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 11663599 ↗
• MalfunctionApr 12, 2021Break; Erratic or Intermittent Display; Communication or Transmission Problem; Break; Erratic or Intermittent Display; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE CAMERA HEAD HAD A DAMAGED CCD CHIP. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE SCREEN OF THIS UNIT FLICKERS WHEN THE CONNECTOR IS MOVED 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 11647127 ↗
• MalfunctionMar 15, 2021No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN UNKNOWN SURGERY, THE SCREEN IN THE SVC CAMERA HEAD NON-AC HD560H WENT WHITE AND SHUT DOWN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11489950 ↗
• MalfunctionMar 1, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT CAPTIONING THE VIDEO. 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 11395980 ↗
• MalfunctionFeb 1, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD NO IMAGE. INCIDENT OCCURRED BEFORE A SHOULDER ARTHROSCOPY. THERE WAS NO DELAY AND A BACK-UP DEVICE WAS AVAILABLE. 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 11261227 ↗
• MalfunctionJan 28, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD A RING ON THE PICTURE, IT WAS NOT FOCUSING. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS HAD NO IMAGE VISIBILITY 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 11244060 ↗
• MalfunctionJan 26, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SVC, CAMERA HEAD, NON-AC, HD560H HAD NO IMAGE. 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 11233273 ↗
• MalfunctionJan 18, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CAMERA HEAD WOULD NOT CONNECT TO THE CAMERA BOX. 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 11184370 ↗
• MalfunctionJan 14, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS GETTING HOT. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO 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 11170118 ↗
• MalfunctionDec 28, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE DID NOT APPEAR IN THE CAMERA HEAD. NO CASE INVOLVED; 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 11083293 ↗
• MalfunctionDec 21, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE "CAMERA HEAD" COULD NOT CAPTURE PHOTOS. 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 11052217 ↗
• MalfunctionNov 24, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD NO IMAGE. 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 10890952 ↗
• MalfunctionNov 17, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD IMAGES WERE NOT DISPLAYED. 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 10854534 ↗
• MalfunctionNov 9, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS BLACK WHEN IT WAS PLUGGED IN. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; NO DELAY, BACKUP DEVICE AVAILABLE. 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 Consequences Or Impact To Patient

  MAUDE report 10807355 ↗
• MalfunctionNov 6, 2020Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT THE CAMERA HEAD WAS HAVING FLICKERING ISSUES. NO CASE 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; No Patient Involvement

  MAUDE report 10804906 ↗
• MalfunctionNov 3, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD NO OUTPUT IMAGE. 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 10778393 ↗
• MalfunctionOct 23, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD DID NOT HAVE VIDEO. NO CASE WAS 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 10727673 ↗
• MalfunctionOct 14, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT CAPTURING 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 Patient Involvement

  MAUDE report 10680595 ↗
• MalfunctionSep 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE CAMERA HEAD HAD A FLICKER IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK UP DEVICE. A DELAY OF 5 MINUTES WAS 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 Known Impact Or Consequence To Patient

  MAUDE report 10607298 ↗