NA 242437Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 10886705028610), received between Dec 1, 2020 and Sep 25, 2026 — classified as 191 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (138 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 191 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Display or Visual Feedback Problem

  It was reported pre-operatively , the COUPLER AC FFL 19 device has an image problem.  This event did not occur during surgery.  There were no reports of injuries, medical intervention or prolonged hospitalization.  All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895660 ↗
• MalfunctionSep 8, 2026Degraded; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670844 ↗
• MalfunctionAug 10, 2026Display or Visual Feedback Problem

  It was reported that during an unknown surgery, it was found that the screen on the COUPLER AC FFL 19 was fogging. The coupler may have a problem. The surgery was completed with no issues using another coupler. There was no surgical delay and no harm to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201093 ↗
• MalfunctionJun 19, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE COUPLER AC FFL 19 DEVICE WAS OUT OF FOCUS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563432 ↗
• MalfunctionJun 9, 2026Display or Visual Feedback Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COUPLER AC FFL 19 DEVICE HAD A POOR IMAGE QUALITY. IT WAS INITIALLY REPORTED THAT, DURING STERILE PROCESSING, IT WAS FOUND THAT THE COUPLER WOULD NOT CLOSE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447772 ↗
• MalfunctionJun 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE COUPLER AC FFL 19 DEVICE WHEN APPROACHED A WHITE SUBJECT, IT CAUSED HALATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406624 ↗
• MalfunctionApr 28, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE COUPLER AC FFL 19 DEVICE CAUSED THE ENTIRE SCREEN TO BE BLURRY WHITE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019614 ↗
• MalfunctionApr 14, 2026Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED THAT PRIOR CONDENSATION WAS FORMING WITHIN THE LENS, WHICH RESULTED IN THE IMAGE APPEARING CLOUDY. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THIS REPORTED ISSUE. NO INJURIES, MEDICAL INTERVENTIONS, OR PROLONGED HOSPITALIZATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879045 ↗
• MalfunctionApr 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE COUPLER AC FFL 19 DEVICE HAD A FOGGED LENS. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766186 ↗
• MalfunctionMar 24, 2026Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE IMAGE OF THE DEVICE REMAINED BLURRY EVEN WHEN FOCUSING. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFTER SURGERY, WHEN WIPING THE COUPLER, BLACK OIL WAS FOUND ON THE LENS. ALTHOUGH CLEANING AND STERILIZING ACCORDING TO THE INSTRUCTIONS, THE COUPLER LENS GETS HEAVILY SOILED. THE SALES REP HAVE ALSO RECEIVED FEEDBACK SUGGESTING THAT GREASE MIGHT BE MELTING FROM THE SCREW CONNECTION TO THE CAMERA HEAD. AFTER CLEANING THE OIL FILM, THE IMAGE WAS CLEAR AND WORKED WITHOUT PROBLEMS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681024 ↗
• MalfunctionMar 19, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE COUPLER AC DEVICE WAS CLOUDY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643625 ↗
• MalfunctionMar 6, 2026Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE COUPLER AC FFL 19 DEVICE HAD SOME CRACKS ON THE INSIDE AND WAS CLOUDY VIEW. THERE WAS A MINUTE DELAY TO GET A BACKUP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536884 ↗
• MalfunctionFeb 20, 2026Scratched Material; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THAT THE COUPLER AC FFL 19 DEVICE COUPLER IS TOO LOOSE AND HAS A BIG SCRATCH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405668 ↗
• MalfunctionJan 26, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING UNSPECIFIED SURGERY, COUPLER AC FFL 19 HAD IMAGE THAT WAS VERY GRAINY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178853 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE COUPLER AC FFL 19 DEVICE WHEN ATTACHING THE KNOB THE SCOPE OF THE COUPLER, BLACK POWDER CAME OUT. ALSO, WHEN YOU HOLD THE KNOB, IT MAKES A SOUND AND IT IS DIFFICULT TO RETURN TO ITS ORIGINAL POSITION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967344 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE COUPLER AC FFL 19 DEVICE WHEN ATTACHING THE KNOB THE SCOPE OF THE COUPLER, BLACK POWDER CAME OUT. ALSO, WHEN YOU HOLD THE KNOB, IT MAKES A SOUND AND IT IS DIFFICULT TO RETURN TO ITS ORIGINAL POSITION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967073 ↗
• MalfunctionNov 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE WAS CLOUDY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569176 ↗
• MalfunctionNov 3, 2025Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION OF THE KNEE FOR AN ANTERIOR CRUCIATE LIGAMENT TEAR, WHILE USING THE COUPLER AC FFL 19 DEVICE, IT WAS OBSERVED THAT STEAM FORMED INSIDE THE LENS OF THE DEVICE CAUSING THE ENTIRE SCREEN TO BECOME CLOUDY AND WHITE. IT WAS REPORTED THAT THE LENS WAS WIPED BUT THE CLOUDINESS DID NOT GO AWAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445323 ↗
• MalfunctionOct 20, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE OF THE KNEE IT WAS OBSERVED THAT THE CAMERA HEAD AC - C-MOUNT DEVICE AND THE COUPLER AC FFL 19 WERE DISPLAYING A CLOUDY IMAGE. IT WAS REPORTED THAT TROUBLESHOOTING OF THE DEVICES WAS PERFORMED, WITH NO SUCCESS. IT WAS REPORTED THAT SPARE DEVICES WERE AVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342327 ↗
• MalfunctionOct 20, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT WHILE IN THE STERILE PROCESSING DEPARTMENT, IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE LENS HAD BUBBLES. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337137 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DEVICE RE-PROCESSING, IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE BUNNY EAR SCREW BACKED OUT AND IS NO LONGER ATTACHED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050117 ↗
• MalfunctionSep 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE COUPLER AC FFL 19 DEVICE WAS FOUND TO BE FOGGY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039911 ↗
• MalfunctionSep 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE WAS FOGGY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038441 ↗
• MalfunctionAug 26, 2025Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE HAD FLUID INSIDE AND WAS FOGGY. IT WAS REPORTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE, WITHOUT ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894000 ↗
• MalfunctionAug 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSALOK ANCHOR W/ORTHOCORD PEEK DEVICE WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893877 ↗