NA 242436Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10886705028634), received between Jun 20, 2019 and Apr 20, 2026 — classified as 2 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (44 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WITH THE PATIENT IN A BEACH CHAIR POSITION, WHEN USING THE CAMERA HEAD AC - C-MOUNT DEVICE AND THE COUPLER AC ZOOM DEVICE, IT WAS OBSERVED THAT WHEN IN THE POSTERIOR VIEWING PORTAL, THE CAMERA HEAD COULD NOT BE FOCUSED. IT WAS REPORTED THAT THE COUPLER WAS AT ITS LIMIT. IT WAS REPORTED THAT AS SOON AS THE PORTAL WAS CHANGED TO THE LATERAL VIEWING PORTAL, THE COUPLER/CAMERA HEAD COULD BE FOCUSED. IT WAS SUSPECTED THAT THIS WAS RELATED TO THE ORIENTATION OF THE HEAD. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 24925579 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, COMPONENT WERE FOUND TO FALL OUT OF THE COUPLER AC ZOOM CHINA LOCAL DEVICE. 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 24261809 ↗
• MalfunctionDec 29, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE COUPLER DEVICE CONTAINED A GAP BETWEEN THE OPTICS LENS AND THE CAMERA-HEAD LENS. WHEN LIGHT ENTERED THE GAP, THE MONITOR IMAGE WAS DISRUPTED AND BECAME UNUSABLE FOR ARTHROSCOPY. THE EFFECT WAS REPRODUCED IN PHOTOGRAPHS USING A LIGHT SOURCE. IT WAS REPORTED THAT THE EVENT WAS IDENTIFIED AT THE SERVICE CENTER AND THERE WAS NO PATIENT INVOLVEMENT. 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 23905880 ↗
• MalfunctionOct 23, 2025Display or Visual Feedback Problem; Mechanical Jam; Display or Visual Feedback Problem; Mechanical Jam

  IT WAS REPORTED THAT THE COUPLER AC ZOOM DEVICE WOULD NOT FOCUS AND THE ATTACHMENT MECHANISM LOOKED TO BE JAMMED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 23365961 ↗
• MalfunctionOct 17, 2025Display or Visual Feedback Problem; Device-Device Incompatibility; Unintended Movement; Display or Visual Feedback Problem; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE COUPLER AC ZOOM DEVICE WAS LOOSE, AND THE IMAGE ON THE MONITOR MOVES A LITTLE BIT DURING THE WHOLE SURGERY. THE COUPLER CANNOT BE SCREWED ON BETTER TO THE CAMERA. THE SCREWS ARE TIGHTENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23327599 ↗
• MalfunctionSep 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X COUPLER AC ZOOM CAMERA ADAPTOR DEVICES THAT WERE USED HAD POOR IMAGING WHEN USED WITH 2X FUSLITEGU_OLYM-ACMI_5.0MMX3.0M, AND 2X CAMERA HEAD AC - C-MOUNT DEVICES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058348 ↗
• 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 2X COUPLER AC ZOOM CAMERA ADAPTOR DEVICES THAT WERE USED HAD POOR IMAGING WHEN USED WITH 2X FUSLITEGU_OLYM-ACMI_5.0MMX3.0M, AND 2X CAMERA HEAD AC - C-MOUNT DEVICES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039290 ↗
• MalfunctionAug 6, 2025Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WAS FROZEN AND WOULD NOT TURN INTO FOCUS. 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 22728193 ↗
• MalfunctionJun 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE SCREEN CONTENTS FAILED TO DISPLAY CLEARLY, THERE WAS AN APERTURE ON SCREEN AND LIGHT LEAKAGE. 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 22192652 ↗
• MalfunctionMay 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, IT WAS NOTED THAT TWO COUPLER DEVICES AND THE CAMERA HEAD DEVICE WERE PRODUCING POOR IMAGE QUALITY, WITH IMAGES APPEARING BLURRY AND GRAINY. THERE WAS A DELAY OF TEN TO FIFTEEN MINUTES IN 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 21962426 ↗
• MalfunctionNov 14, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS NOT FUNCTIONING CORRECTLY. DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN THE OPTICAL SYSTEM. THEY USED ANOTHER COUPLER TO COMPLETE THE CASE WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686070 ↗
• MalfunctionNov 12, 2024Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED FROM THAILAND THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVE THAT THE INTERNAL LENS OF THE COUPLER AC ZOOM DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THAT THE ARTHROSCOPIC IMAGE WAS SEEN DARK AND INCOMPLETE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667602 ↗
• MalfunctionAug 15, 2024Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE WHILE USING THE COUPLER AC ZOOM DEVICE, APPROXIMATELY AFTER FIFTY MINUTES THE IMAGE WAS FOGY AND THE CAMERA WAS WITHOUT A DRAPE. THE SURGEON WIPED SEVERAL TIMES BUT THE MOISTURE APPEARED AGAIN AFTER FEW MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996321 ↗
• MalfunctionAug 15, 2024Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE WHILE USING THE COUPLER AC ZOOM DEVICE, APPROXIMATELY AFTER FORTY MINUTES THE IMAGE WAS FOGGY, THE CAMERA WAS WITHOUT A DRAPE, THE SURGEON WIPED THE MOISTURE SEVERAL TIMES BUT IT APPEARED AGAIN AFTER FEW MINUTES. IT WAS UNKNOWN IF THERE WAS A DELAY TO THE PROCEDURE, OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994596 ↗
• MalfunctionJul 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPY PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WAS FOGGY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWO MINUTE 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 19653283 ↗
• MalfunctionJun 20, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE COUPLER AC ZOOM DEVICE HAD ISSUES USING A FUSLITEGU_OLYM-ACMI_5.0MMX3.0M DEVICE DURING A MICROSCOPIC CASE AND FOUND A BROKEN COUPLER DEVICE. IT WAS REPORTED THAT THE BRIGHTNESS IN THE DEEP PARTS OF THE BELLY WHILE USING LIGHT CORD AND COUPLER BUNNY EARS BENT. IT WAS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 19575308 ↗
• MalfunctionJan 31, 2024Display or Visual Feedback Problem; Unintended Movement; Display or Visual Feedback Problem; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE MIDDLE OF THE PICTURE ON THE COUPLER AC ZOOM DEVICE WAS DISTORTED. IT WAS FURTHER REPORTED THAT PERHAPS BECAUSE THE COUPLER'S GRIPPING MECHANISM WAS WEAK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617846 ↗
• MalfunctionDec 20, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED FROM THE SALES REP THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WAS NOT FOCUSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366631 ↗
• MalfunctionOct 24, 2023Display or Visual Feedback Problem; Difficult or Delayed Separation; Display or Visual Feedback Problem; Difficult or Delayed Separation

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE COUPLER AC ZOOM DEVICE PICTURE WAS NOT CENTERED ON THE SCREEN AND THE COUPLER MAKES NOISES WHEN PRESSED TO CAPTURE THE OPTIC. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17994853 ↗
• MalfunctionOct 13, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A UROLOGY PROCEDURE ON (B)(6) 2023. THE COUPLER AC ZOOM DEVICE WAS BEING USED WHEN THE SURGEON REPORTED FOGGING ON A CYSTO/URETEROSCOPE WHEN HE SWAPPED FROM THE CYSTO SCOPE TO THE FLEXIBLE URETEROSCOPE. THE PHYSICIAN FINISHED THE CASE WITH THE EQUIPMENT. THE CASE WAS DELAYED BY AN ADDITIONAL 10-15 MINUTES BUT NO ADVERSE PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930256 ↗
• MalfunctionJun 6, 2023Display or Visual Feedback Problem; Device-Device Incompatibility; Display or Visual Feedback Problem; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE FREQUENTLY FOGGED-UP; AND ITS BUCKLE DID NOT REBOUND SMOOTHLY, MAKING IT IMPOSSIBLE TO CLAMP THE MIRROR TIGHTLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074942 ↗
• MalfunctionFeb 21, 2023Display or Visual Feedback Problem; Unintended Movement; Display or Visual Feedback Problem; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A UROLOGY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WAS LOOSE AND WOULD NOT STAY IN FOCUS. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413907 ↗
• MalfunctionFeb 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WAS CLICKING WHEN TRYING TO ZOOM. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372008 ↗
• MalfunctionDec 29, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE COUPLER AC ZOOM DEVICE WOULD NOT FOCUS AND KEPT CAUSING THE PICTURE TO BLUR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067996 ↗
• MalfunctionNov 22, 2022Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE FOCUS FUNCTION ON THE COUPLER AC ZOOM DEVICE COULD NOT BE ADJUSTED PROPERLY BECAUSE THE RANGE OF MOTION OF THE FOCUS RING WAS LIMITED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845644 ↗