Depuy Synthes Evo4K220 (UDI 00817613020543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00817613020543), received between Oct 18, 2019 and Aug 3, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE DID NOT DISPLAY IMAGE ON THE SCREEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268747 ↗
• MalfunctionMay 14, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING RETURN TESTING, IT WAS OBSERVED THAT THE SCREEN ON THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE WAS BLACK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825366 ↗
• MalfunctionDec 4, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN CHINA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE SCREEN SHOWED NO VIDEO INPUT WHILE PREPARING FOR THE OPERATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944885 ↗
• MalfunctionDec 4, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE IMAGING DEVICE WOULD NOT DISPLAY IMAGE. ACCORDING TO THE REPORT, THE IMAGES COULD NOT BE DISPLAYED IN THE LIVE VIDEO MENU. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944614 ↗
• MalfunctionNov 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K GLITCHES WITH PICTURES AND ITS ACTING VERY STRANGELY AFTER PICTURES ARE TAKEN, ITS FREEZING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923962 ↗
• MalfunctionNov 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K GLITCHES WITH PICTURES AND ITS ACTING VERY STRANGELY AFTER PICTURES ARE TAKEN, ITS FREEZING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923458 ↗
• MalfunctionApr 8, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY CLINICAL EVALUATOR VIA EMAIL, THAT IT APPEARS TO BE A GLITCH IN AN EVO4K VIDEO RECORDER, PICTURE ON SCREEN IS OFF, DOES NOT SHUT DOWN APPROPRIATELY. NO PATIENT INVOLVEMENT OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933965 ↗
• MalfunctionFeb 14, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A DEMO THE EVO4K DEVICE WAS UNABLE TO RECOGNIZE THE VIDEO SIGNAL COMING FROM THE PUREVUE CCS VIA A QUAD 3G-SDI CABLE CONNECTION. FURTHER, THE CHANNEL SELECTION ICON THAT TYPICALLY APPEARS IN THE TOP RIGHT HAND CORNER OF THE LIVE VIDEO SCREEN (IMG_1128) WAS NOT VISIBLE. THE ¿VIDEO INPUT¿ TAB WITHIN THE SYSTEM SETTINGS WAS ALSO NOT VISIBLE. TO TROUBLESHOOT, THE DEVICE WAS RESTARTED MANUALLY. THE DEVICE WAS THEN RESET USING A FACTORY RESET THROUGH THE SETTINGS MENU. THIS WAS ATTEMPTED TWICE. ADDITIONAL CABLE CONNECTIONS WERE TRIED INCLUDING SINGLE 3G-SDI CONNECTION FROM THE PUREVUE CCS TO EACH OF THE 4 SDI-IN PORTS ON THE EVO4K DEVICE. NONE OF THESE CABLE CONNECTIONS FIXED THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714439 ↗
• MalfunctionJan 16, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE MITEK VIDEO CART WAS SET UP AND WHEN THE LIGHT CORD AND CAMERA WERE PLUGGED IN, THE MONITOR AND EVO4K STARTED TO DISPLAY A NUMBER OF COLORS IN STATIC FORMAT. THE CAMERA CORD WAS PULLED OUT AND PLUGGED BACK IN - SAME STATIC PICTURE DISPLAYED. A REPLACEMENT CAMERA WAS USED AND DISPLAYED THE SAME RESULT. THE MONITOR WAS POWERED OFF/ON AND THE STATIC COLOR SCHEME WAS STILL PRESENT. FINALLY, THE CCS WAS POWERED OFF WHILE CONFIRMING ALL WIRING IN THE BACK WAS CORRECT AND CONNECTED PROPERLY. THE CCS WAS POWERED BACK ON AND CAMERA/LIGHT CORD PLUGGED BACK IN. ONCE AGAIN THE STATIC COLOR SCHEME REAPPEARED. THE COMPETITIVE TOWER, IN THE ROOM, WAS POWERED ON AND WAS USED FOR VIDEO ON THE CASE. OUR PUMP AND SHAVER CONTINUED TO BE USED FROM THE PUREVUE TOWER. THERE WAS A MINIMAL DELAY (UNDER 3 MINUTES) TO CONNECT NEW VIDEO. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: Not Applicable

  MAUDE report 9595908 ↗
• MalfunctionOct 18, 2019Image Display Error/Artifact; Intermittent Communication Failure; Image Display Error/Artifact; Intermittent Communication Failure

  AS REPORTED PER THE CUSTOMER VIE EMAIL, THE EVO 4K SYSTEM WAS WORKING AT THE OLC ON THE FRIDAY USING A SINGLE SDI INPUT. ON SATURDAY AFTER BOOTING UP THE TOWER THEY RECEIVED AN ERROR ¿NO VIDEO INPUT. THIS WAS IN A CADAVERIC SETTING THEREFORE THERE IS NO PATIENT INVOLVEMENT. THIS IS ALL THE INFORMATION THE CUSTOMER HAS AT THIS TIME. THIS COMPLAINT IS FOR ONE (1) IMAGE MANAGEMENT SYSTEM THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9210147 ↗