NA 242435Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886705028627), received between Jan 30, 2020 and Aug 15, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (24 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE CAMERA HEAD AC - C-MOUNT DEVICE AND THE COUPLER AC FFL 22 DEVICE WAS BEING USED WHEN HE MONITOR STARTED TO HAVE STATIC COLORED BAR CODES. THE CAMERA HEAD WAS TAKEN OUT AND REINSERTED. AFTER ABOUT 10 MINUTES THE MONITOR AGAIN HAD STATIC-COLORED BARS. THE CASE WAS COMPLETED SUCCESSFULLY BY SWAPPING OUT THE CAMERA HEAD WITH ANOTHER CAMERA HEAD. IT WAS NOTED THAT THERE WAS NO CLEAR VISUALIZATION. THE COUPLER IS BLURRY. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814960 ↗
• MalfunctionMar 11, 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 WHEN USING THE COUPLER AC FFL 22 DEVICE, THE IMAGE WAS POOR, AND THE COUPLER MAY HAVE SOME WATER THAT HAD LEAKED INSIDE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577539 ↗
• MalfunctionNov 28, 2024Moisture Damage; Device Contaminated During Manufacture or Shipping; Moisture Damage; Device Contaminated During Manufacture or Shipping

  REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, (X2) COUPLER AC FFL 22 DEVICES HAD WATER INSIDE AND (X2) COUPLER AC FFL 22 DEVICES WERE NOT HOLDING LENS ALONG WITH A CAMERA HEAD AC - C-MOUNT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COUPLER AC FFL 22 DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. 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 20805061 ↗
• MalfunctionNov 28, 2024Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping; Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, (X2) COUPLER AC FFL 22 DEVICES HAD WATER INSIDE AND (X2) COUPLER AC FFL 22 DEVICES WERE NOT HOLDING LENS ALONG WITH A CAMERA HEAD AC - C-MOUNT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COUPLER AC FFL 22 DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. 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 20805060 ↗
• MalfunctionNov 28, 2024Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping; Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, (X2) COUPLER AC FFL 22 DEVICES HAD WATER INSIDE AND (X2) COUPLER AC FFL 22 DEVICES WERE NOT HOLDING LENS ALONG WITH A CAMERA HEAD AC - C-MOUNT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COUPLER AC FFL 22 DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. 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 20805053 ↗
• MalfunctionNov 28, 2024Moisture Damage; Device Contaminated During Manufacture or Shipping; Moisture Damage; Device Contaminated During Manufacture or Shipping

  REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, (X2) COUPLER AC FFL 22 DEVICES HAD WATER INSIDE AND (X2) COUPLER AC FFL 22 DEVICES WERE NOT HOLDING LENS ALONG WITH A CAMERA HEAD AC - C-MOUNT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COUPLER AC FFL 22 DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. 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 20805052 ↗
• MalfunctionNov 15, 2024Break; Degraded; Device Contaminated During Manufacture or Shipping; Break; Degraded; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CLIPS WERE CORRODED AND LENS SEEMED DISLODGED ON THE DEVICE. DURING SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: VISUAL: FOREIGN. SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696764 ↗
• MalfunctionNov 13, 2024Degraded; Difficult to Open or Close; Device Contaminated During Manufacture or Shipping; Degraded; Difficult to Open or Close; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE SPRINGS ON THE COUPLER AC FFL 22 DEVICE HAD INTERNAL CORROSION AND THE CLIPS COULD NOT BE ADJUSTED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673711 ↗
• MalfunctionNov 12, 2024Break; Device Reprocessing Problem; Use of Device Problem; Device-Device Incompatibility; Break; Device Reprocessing Problem; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COUPLER AC FFL 22 DEVICE CLIPS WERE NOT FUNCTIONING AND THE SCOPE COULD NOT BE ATTACHED. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666889 ↗
• MalfunctionOct 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE COUPLER AC FFL 22 DEVICE WAS EXTREMELY BLURRY AND PINK AND WAS NOT PRESENTING A PICTURE. THERE WAS ABOUT A MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532866 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Mechanical Jam; Contamination /Decontamination Problem; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THE COUPLER AC FFL 22 DEVICE WAS HAVING ISSUES WITH THE SPRING MECHANISM STICKING AND NOT GRIPPING THE SCOPE CORRECTLY. NO ASSOCIATED CASE INFORMATION. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159182 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Mechanical Jam; Contamination /Decontamination Problem; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THE COUPLER AC FFL 22 DEVICE WAS HAVING ISSUES WITH THE SPRING MECHANISM STICKING AND NOT GRIPPING THE SCOPE CORRECTLY. NO ASSOCIATED CASE INFORMATION. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159145 ↗
• MalfunctionJul 5, 2024Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE COUPLER DEVICE COUPLER HAD MOISTURE WHICH CAUSED A DISTORTED IMAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE 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 19684422 ↗
• MalfunctionMay 20, 2024Display or Visual Feedback Problem; Moisture Damage; Display or Visual Feedback Problem; Moisture Damage

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE HAD WATER DAMAGE AND IT DISTORTED THE IMAGE. 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 19350391 ↗
• MalfunctionApr 30, 2024Display 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 FIXED FOCAL LENGTH COUPLER 22MM DEVICE HAD WATER THAT INFILTRATED INSIDE THE COUPLER WHICH DID NOT ALLOW FOR A USABLE 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 19215585 ↗
• MalfunctionJun 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WOULD NOT FOCUS. ACCORDING TO THE REPORT, THEY DIALED TO THE END OF RANGE BOTH WAYS BUT THERE WAS NO CHANGE TO IMAGE FOCUS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110542 ↗
• MalfunctionJun 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE COULD NOT BE FOCUSED WHILE IN USE WITH A CAMERA DEVICE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17073638 ↗
• MalfunctionJan 9, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126931 ↗
• MalfunctionOct 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAT A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640377 ↗
• MalfunctionOct 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAT A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640274 ↗
• MalfunctionOct 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAT A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640140 ↗
• MalfunctionOct 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAT A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640121 ↗
• MalfunctionOct 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAT A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640052 ↗
• MalfunctionOct 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT A FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633293 ↗
• MalfunctionOct 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2022 , IT WAS OBSERVED THAT A FIXED FOCAL LENGTH COUPLER 22MM DEVICE WAS FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633222 ↗