Arthrex® AR-3200-0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867216549), received between Jun 14, 2018 and Apr 12, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Intermittent Loss of Power; Intermittent Loss of Power

  ON 03/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0020 CCUS LIGHT ENGINE WAS SHUTTING OFF INTERMITTENTLY. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097128 ↗
• MalfunctionApr 1, 2024Defective Device; Defective Device

  ON 3/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0020 CCU LIGHT SOURCE WOULD NOT EMIT LIGHT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014038 ↗
• MalfunctionDec 8, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 11/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06401295 THAT AN AR-3200-0020 SYNERGY CAMERA CONTROL UNIT HAD A FUZZY IMAGE AND LINES THROUGHOUT VISION. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292376 ↗
• MalfunctionNov 20, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0020 CCUS SCREEN WOULD DISPLAY STATIC, GREEN LINES, AND HALO IMAGES WHEN THE CAMERA WAS PLUGGED IN. THIS OCCURRED DURING A CASE, IT SEEMS LIKE THEY ARE SHORTING OUT AND THE PRONGS WERE BENT ON THE CABLES CONNECTING TO THE CCU BUT STILL WOULD CONNECT. THEY REPLACED THE CCU AND CONTINUED SUCCESSFULLY WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169632 ↗
• MalfunctionNov 20, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0020 CCUS SCREEN WOULD DISPLAY STATIC, GREEN LINES AND HALO IMAGES WHEN THE CAMERA WAS PLUGGED IN. THIS OCCURRED DURING A CASE. IT SEEMS LIKE THEY ARE SHORTING OUT AND THE PRONGS WERE BENT ON THE CABLES CONNECTING TO THE CCU BUT STILL WOULD CONNECT. THEY REPLACED THE CCU AND CONTINUED SUCCESSFULLY WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169346 ↗
• MalfunctionNov 10, 2023Defective Device; Defective Device

  ON 10/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06062352 THAT AN AR-3200-0020 CCU CONNECTOR IS DAMAGED. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111755 ↗
• MalfunctionNov 10, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0020 CCU WAS NOT TAKING PHOTOS OR VIDEOS WITH A CAMERA HEAD OR TABLET IN MULTIPLE CASES. THE ROOT CAUSE WAS DUE TO DAMAGED PINS AT THE LOCATION WHERE IT WAS PLUGGED INTO THE CAMERA HEAD. THIS WAS DISCOVERED DURING CASES WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111085 ↗
• MalfunctionOct 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 09/15/2023, IT WAS REPORTED BY AN SALES REPRESENTATIVE VIA SEMS-06033363 THAT AN AR-3200-0020 CCU IMAGE IS GRAINY. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922482 ↗
• MalfunctionSep 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SAS PROCEDURE THE LIGHT SOURCE BEGINS TO FLASH AS ONE APPROACHES AN OBJECT. IN ADDITION, THE IMAGE EXPORT TO THE SURGEON'S IPAD DOES NOT ALWAYS WORK BECAUSE THE IPAD CAN NOT BE RECOGNIZED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824229 ↗
• MalfunctionSep 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU ARTHREX SYNERGY UHD4 MATRIX CAMERA BOX HAS LINES APPEARING ON IT WHEN PLUGGED IN. THE SCOPE WAS SWAPPED OUT, BUT THE PROBLEM STILL PERSISTED. THE CAMERA WAS PLUGGED IN AGAIN FOR THE NEXT CASE, AND THE ISSUE REMAINED THE SAME. THE LINES WILL NOT GO AWAY. THE CAMERA BOX WAS SWAPPED OUT AND THIS RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744021 ↗
• MalfunctionSep 14, 2023Connection Problem; Connection Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU SOURCE WAS MISSING AND COULD NOT ROUTE TO ANY MONITORS. THE CCU AND TABLET WERE REBOOTED TO TROUBLESHOOT, BUT THE ISSUE WAS NOT RESOLVED. THE CASE WAS COMPLETED BY BRINGING IN A MOBILE SCREEN, CAUSING A DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743290 ↗
• MalfunctionSep 11, 2023Unexpected Shutdown; Unexpected Shutdown

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU WAS HAVING CONNECTIVITY ISSUES; IT WOULD DISCONNECT WHILE IN USE AND WOULD ONLY CONNECT UPON RESTARTING. ALSO, THE CAMERA HEAD BUTTONS ARE LOSING FUNCTIONALITY AND HAVE BECOME UNRESPONSIVE IN THE MIDDLE OF A CASE, AND THEN WOULD HAVE TO HAVE THE IMAGES TAKEN FROM THE TABLET. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724562 ↗
• MalfunctionAug 31, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 8/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU AND ANOTHER CCU WITH AN UNKNOWN PART NUMBER HAD AN ISSUE. THE CAMERA WAS SHOWING INTERMITTENT STATIC ON THE DISPLAY DURING PROCEDURES. THIS ONLY HAPPENED WHEN THE CABLE WAS MOVED. THEY HAD TESTED MULTIPLE CAMERAS ON MULTIPLE UNITS, AND IT ONLY SEEMED TO BE HAVING AN ISSUE WITH TWO CONSOLES. THIS WAS DISCOVERED DURING USE IN UNSPECIFIED PROCEDURES WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/22/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING UNSPECIFIED ARTHROSCOPIC PROCEDURES. IT WAS DETERMINED THAT ONLY THE TWO CCUS MALFUNCTIONED, NOT THE CAMERA HEAD. THE CCUS WERE USED TO COMPLETE THE PROCEDURES SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENTS, AND NO CASE DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662683 ↗
• MalfunctionAug 14, 2023Connection Problem; Connection Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU AND A E830343 ELO 15 INCH WIDESCREEN ARE EXPERIENCING LOST CONNECTION. THEY STATED SYNERGY LOST CONNECTION.

  Patient problems: Insufficient Information

  MAUDE report 17541959 ↗
• MalfunctionAug 4, 2023Display or Visual Feedback Problem; Connection Problem; Display or Visual Feedback Problem; Connection Problem

  ON 7/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU WOULD NOT WHITE BALANCE AND LOST CONNECTIVITY WITH THE SCREEN. THE SCREEN THEN WENT TO SLEEP. THE ISSUE WAS DISCOVERED DURING THE CASE. NO ADVERSE EVENTS WERE REPORTED. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464868 ↗
• MalfunctionJan 30, 2023Thermal Decomposition of Device; Electrical /Electronic Property Problem; Melted

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0020 CCU HAD A FAULT ON STORX CONNECTOR WHERE IT BURNT/MELTED CORD AND METAL. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 1/10/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA PHONE: THE PLUG INTO THE CCU WAS BURNT ON THE INSIDE, AND ALSO THE CABLE WAS BURNT AND THE METAL WAS MELTED WHERE IT CONNECTED. THE STAFF DID NOT NOTICE ANY BURNT SMELL OR SMOKE AND NO ONE WAS HARMED. THIS OCCURRED DURING AN UNSPECIFIED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263365 ↗
• InjuryJun 14, 2018Overheating of Device

  IT WAS REPORTED VIA FDA MAUDE LETTER (MW5077001) THAT A PATIENT HAD ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY. AFTER SURGERY IT WAS NOTED THERE WAS A SMALL BREAK IN THE SKIN AT THE RIGHT LOWER QUADRANT OF THE ABDOMEN (2 CM X 2 CM) AS WELL AS ERYTHEMATOUS. STAFF WAS UNABLE TO DETERMINE IF RELATED TO FRICTION OF MOVEMENT OF TROCAR OR RELATED TO TEMPERATURE OF CAMERA LIGHT THAT WAS TOUCHING SKIN. ANTIBIOTIC OINTMENT WAS APPLIED AND DRY STERILE DRESSING. WOUND DID NOT HEAL ACCORDINGLY. ACCORDING TO PATIENT, THE WOUND DID NOT HEAL AND SHE THEN SAW A WOUND CARE PHYSICIAN AND HAD AN EXCISION OF CHRONIC NON-HEALING ABDOMINAL WOUND. DIAGNOSED WITH FULL-THICKNESS BURN. FOLLOW UP INFORMATION OBTAINED: FACILITY REPORTS THE SERIAL NUMBER FOR THE LIGHT SOURCE WAS (B)(4) (NUMBER NOT LOCATED IN ARTHREX SYSTEM). LENS WAS REPORTED TO BE (B)(4). FACILITY RISK MANAGER REPORTS "IT WAS NOT APPARENT IF THIS WAS RELATED TO FRICTION OF MOVEMENT OF TROCAR ON SKIN AS LAPAROSCOPIC CAMERA WAS MANIPULATED DURING PROCEDURE OR IF IT WAS RELATED TO TEMPERATURE OF CAMERA LIGHT HEATING METALLIC SURFACES WHICH TOUCHED THE SKIN. PER (SURGEON), THE PATIENT'S (B)(6) AND AS SUCH HER ABDOMINAL GIRTH CAUSED CONTACT WITH PORTIO

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 7600201 ↗