LENS 4K CCU 72205059Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00885556720844), received between Jun 10, 2020 and Feb 12, 2026 — classified as 1 injury, 41 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY PROCEDURE, IT WAS NOTICED THE LENS 4K CCU BECAME INOPERABLE WHEN PLUGGING IN THE CAMERA HEAD. 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 24321513 ↗
• MalfunctionFeb 10, 2026No Display/Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT BEFORE A PROCEDURE, THE CAMERA CONTROL UNIT HAD AN UNSPECIFIED FAILURE. THE PROCEDURE WAS PERFORMED, WITH A SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACKUP. THE PATIENT WAS EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305767 ↗
• MalfunctionFeb 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY, THE CAMERA CONTROL UNIT BECAME INOPERABLE AFTER THE CAMERA HEAD WAS CONNECTED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN OLYMPUS DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268320 ↗
• MalfunctionJan 26, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN RCR, A LENS 4K CCU WIFI VERSION WAS NOT DETECTING THE PEN DRIVE. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179891 ↗
• MalfunctionSep 23, 2025Calibration Problem; Optical Problem; Calibration Problem; Optical Problem

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE, IT WAS NOTICED THAT A CAMERA CONTROL UNIT HAD OVEREXPOSURE OF LIGHT. BEFORE THE CASE, THERE WAS TROUBLE DOING WHITE BALANCE INITIALLY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A STORZ STACK COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123077 ↗
• MalfunctionJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RECORDING OPTION OF THE CCU WAS NOT WORKING. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199727 ↗
• MalfunctionMay 28, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE LENS CCU HAD A WIFI DISCONNECTION ISSUE AND NEEDED TO SHUT DOWN TO RESTORE THE CONNECTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102651 ↗
• MalfunctionMay 26, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RECORDING OF THE LENS 4K CCU WAS NOT WORKING. 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 22085186 ↗
• MalfunctionApr 1, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BRIGHTNESS OF THE LENS CAMERA CONTROL UNIT WENT UP AND DOWN AUTOMATICALLY. THE PROCEDURE WAS COMPLETED USING A 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 21749296 ↗
• MalfunctionMar 17, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LENS 4K ICONS WERE FREEZING, RECORDING WAS NOT DONE THROUGH WIFI IN THE TAB AND ALSO THROUGH THE PENDRIVE SLOT. THE PROCEDURE WAS COMPLETED USING 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 21627815 ↗
• MalfunctionFeb 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE LENS 4K CCU DIDN¿T OUTPUT TOP PORT SIGNAL TO A PERIPHERAL DEVICE. SURGERY WAS COMPLETED WITH THE SAME FAULTY DEVICE, MANUALLY TAKING STILL IMAGES. THERE WAS A DELAY OF 40 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461883 ↗
• MalfunctionJan 22, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF ONE (1) LENS 4K CAMERA CONTROL UNIT WAS NOT WORKING. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207360 ↗
• MalfunctionSep 4, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE CAMERA CONTROL UNIT HAD A FLICKERING IMAGE ISSUE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 20135697 ↗
• MalfunctionMay 27, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE CAMERA CONTROL UNIT IMAGE WAS FLICKERING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. 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 19400605 ↗
• MalfunctionMar 10, 2024Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING AN ACL, A LENS 4K CCU FROZE, IT WAS NOT RECORDING NOR CAPTURING IMAGES. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18872216 ↗
• MalfunctionOct 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL, A LENS 4K CCU´S LIGHT SOURCE WAS NOT WORKING. SURGERY RESUMED AFTER A GREATER DELAY WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854470 ↗
• MalfunctionSep 14, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE IMAGE OF THE LENS CCU FLICKER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749941 ↗
• MalfunctionMay 3, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN ACL THE GLASS IN THE IN THE PORT OF THE LENS 4K CAMERA CONTROLLER WAS CRACKED, LIGHT WAS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY GREATER THAN 30 MINUTES. THE PATIENT WAS ANESTHETIZED DURING THE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862104 ↗
• MalfunctionJan 3, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LIGHT SOURCE OF THE LENS 4K WAS NOT WORKING. 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 16085464 ↗
• MalfunctionMay 4, 2022Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE LENS 4K CONTROL UNIT STARTED TO SMELL AFTER ABOUT 30 MINUTES AND THE SYSTEM DROPPED OUT. THE UNIT OVERHEATED/BECAME HOT TO THE TOUCH, ONCE THE SYSTEM COOLED DOWN, IT RUN AGAIN. THE CASE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274302 ↗
• MalfunctionFeb 23, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE LENS 4K CONTROLLER STARTED TO SMELL AFTER ABOUT 30 MIN AND THE LIGHT WENT OUT. AFTER A RESTART, IT RAN BRIEFLY AND THEN THE SYSTEM DROPPED OUT COMPLETELY. THE DEVICE OVERHEATED AND BECAME HOT TO THE TOUCH. ONCE THE SYSTEM COOLED DOWN, IT WORKED AGAIN. THE INCIDENT OCCURRED WHILE SETTING-UP FOR THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585295 ↗
• MalfunctionNov 17, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE LENS 4K CCU OVERHEATED AND MADE A FOUL SMELL. INSTRUMENTS OUTSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825895 ↗
• MalfunctionAug 24, 2021Connection Problem; Unexpected Shutdown; Connection Problem; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE LENS 4K CONSOLE WOULD RESTART AUTOMATICALLY AND THE MONITOR WOULD FLICKER WHILE CONNECTING THE CAMERA HEAD TO THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360262 ↗
• MalfunctionAug 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A MENISCECTOMY SURGERY, THE CAMERA HEAD STOPS TRANSMITTING THE 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 12257335 ↗
• InjuryJul 28, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE IN A SHOULDER SURGERY, THE IMAGE ON THE "LENS 4K CAMERA CONTROL UNIT" DISAPPEARED. THE FAN WAS WORKING, NO LED LIGHTS ON. I TURNED IT OFF, AND STARTED IT AGAIN. SMITH AND NEPHEW LOGO APPEARED ON THE SCREEN (ONLY THE SMITH AND NEPHEW LOGO ON BLACK SCREEN), NOTING ELSE HAPPENED. I RESTARTED IT AGAIN, CHECKED THE CAMERA CONNECTION, IT WORKED AND THEN AFTER ABOUT 10 MINUTES THE SAME THING HAPPENED AGAIN. AFTER THAT THE SURGEONS DECIDED TO CANCEL THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242129 ↗