LENS 4K Camera Head 72205058Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00885556720790), received between Jul 6, 2020 and Apr 29, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (45 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Display or Visual Feedback Problem; Overheating of Device

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A CAMERA HEAD WAS HEATING UP. THE PROCEDURE WAS RESUMED, AFTER A 5-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024738 ↗
• MalfunctionMar 9, 2026Overheating of Device; Optical Distortion

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A CAMERA HEAD WAS HEATING UP AND HAD A BLURRY IMAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546149 ↗
• MalfunctionFeb 26, 2026Overheating of Device

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPY, IT WAS NOTICED THAT ONE (1) CAMERA HEAD WAS OVERHEATING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465596 ↗
• MalfunctionFeb 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY PROCEDURE, ONE (1) CAMERA HEAD HAD A FAULTY CHORD. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, USING A COMPETITOR OLYMPUS CCU AS A BACKUP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265296 ↗
• MalfunctionNov 24, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, A CAMERA HEAD WAS GETTING HEATED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639328 ↗
• MalfunctionJul 30, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD WAS HAVING GLITCHES OBSERVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 22666356 ↗
• MalfunctionJun 13, 2025Overheating of Device; Optical Obstruction; Overheating of Device; Optical Obstruction

  IT WAS REPORTED THAT, DURING SURGERY, THE CAMERA HEAD HEATED UP AND THE VIEW BECAME FOGGY. THERE WAS NO DAMAGE TO THE PATIENT OR USER DUE TO THE OVERHEATING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200102 ↗
• MalfunctionMay 6, 2025Erratic or Intermittent Display; Optical Obstruction; Erratic or Intermittent Display; Optical Obstruction

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD WAS GIVING FLICKERING AND UNSTABLE IMAGE WITH GREEN OR WHITE DOTS AND LINES WHEN SEEN ON THE MONITOR. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969816 ↗
• MalfunctionMay 24, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING SURGERY, THE CAMERA HEAD DISPLAYED A FLICKERING IMAGE. SURGERY WAS COMPLETED WITH THE SAME 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 19393402 ↗
• MalfunctionApr 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE CAMERA HEAD WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR 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 19122055 ↗
• MalfunctionDec 20, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAMERA HEAD HAD A HALATION AND A WHITE IMAGE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A 40 MINUTES DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365331 ↗
• MalfunctionNov 5, 2023Overheating of Device; Moisture or Humidity Problem; Optical Obstruction; Overheating of Device; Moisture or Humidity Problem; Optical Obstruction

  IT WAS REPORTED THAT DURING SET UP, THE LENS 4K CAMERA HEAD'S IMAGE WAS FOUND TO BE FOGGY AND GETS HOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070848 ↗
• MalfunctionJan 10, 2023Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE CAMERA HEADS HAD INTERNAL HUMIDITY AFFECTING THE IMAGE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134123 ↗
• MalfunctionJan 9, 2023Overheating of Device; Electromagnetic Compatibility Problem; Optical Discoloration; Overheating of Device; Electromagnetic Compatibility Problem; Optical Discoloration

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE CAMERA HEAD PRESENTED IMAGE FAILURE, INTERFERENCE, PINK TONE AND TEMPORARY IMAGE LOSS. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120691 ↗
• MalfunctionJan 9, 2023Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE CAMERA HEAD HAD INTERNAL HUMIDITY AFFECTING THE IMAGE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120632 ↗
• MalfunctionDec 8, 2022Overheating of Device; Optical Obstruction; Overheating of Device; Optical Obstruction

  IT WAS REPORTED THAT THE CAMERA HEAD HAD CONDENSATION INSIDE, THAT LEADS TO FOGGING ONCE THE CAMERA HEAD WAS PLUGGED IN AND WARMED UP. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942120 ↗
• MalfunctionOct 18, 2022No Display/Image; Overheating of Device; No Display/Image; Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD HAD NO PICTURE UNEXPECTEDLY AFTER PLUG-IN AND WAS WARMING UP. NO CASE WAS REPORTED. THEREFORE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625396 ↗
• MalfunctionJan 3, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SURGERY THE LENS 4K CAMERA CONTROL UNIT WAS REBOOTING ON ITS OWN. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13141827 ↗
• MalfunctionDec 29, 2021Overheating of Device; Optical Obstruction; Overheating of Device; Optical Obstruction

  IT WAS REPORTED THAT, DURING PROCEDURE USING THE 'CAMERA HEAD', THE LENS WAS FOGGY. THIS EVENT OCCURRED AS THE DEVICE WAS CONTINUOUSLY HEATING DURING USE. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING THE SAME REPORTED DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114329 ↗
• InjuryAug 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A MENISCECTOMY SURGERY, THE CAMERA HEAD STOPS TRANSMITTING IMAGE UNCONTROLLED. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257336 ↗
• MalfunctionJul 22, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY, WHEN THE CAMERA HEAD WAS PLUGGED IN, THE SCREEN TURNED BRIGHT GREEN. THEN THE CAMERA HEAD WAS REMOVED AND REINSERTED INTO THE LENS 4K SYSTEM AND THE SCREEN TURNED YELLOW AND PURPLE (SPLIT INTO 4 SECTIONS WITHIN THE SCREEN). THE CAMERA HEAD WAS REMOVED AND REPLACED WITH THE SPARE AS IT WAS NOT FUNCTIONING AS INTENDED. THE PROCEDURE HAD TO BE CANCELED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214234 ↗
• MalfunctionJun 7, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT TAKING PHOTOS. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952902 ↗
• MalfunctionJun 7, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE CAMERA HEAD SOMETIMES DID NOT DISPLAY ARTHROSCOPY IMAGE AND STILL DISPLAYED COLOR BARS ON THE DISPLAY. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952800 ↗
• MalfunctionMay 25, 2021No Display/Image; Material Deformation; No Display/Image; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION THE LENS 4K CAMERA HEAD WAS SCRATCHED. A BACKUP DEVICE WAS AVAILABLE AND NO PATIENT INJURY NOR DELAY WAS REPORTED. 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 11877063 ↗
• MalfunctionMay 14, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP OF THE PROCEDURE, THE LEFT BUTTON OF THE CAMERA HEAD WAS NOT TAKING A PICTURE. 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 11828568 ↗