Separator® Access System C0680Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915115074), received between Feb 19, 2020 and Mar 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: LES CLIPS NE FERMENT PAS /PAS DE MAINTIEN DE LA PRISE. TRANSLATION: CLIPS DO NOT CLOSE / NO HOLD ON THE CLAMP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 24-FEB-2022: THERE WAS NO PATIENT INJURY. 3 CLIPS WERE TRIED ON THE PATIENT. THE ISSUE WAS RESOLVED BY TAKING ANOTHER LOT. THE CLIPS ARE AVAILABLE FOR RETURN. THE SINGLE-USED DEVICES WERE NOT REUSED, THEY USED OTHER CLIPS OF THE SAME LOT. TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847079 ↗
• MalfunctionMar 22, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: LES CLIPS NE FERMENT PAS /PAS DE MAINTIEN DE LA PRISE. TRANSLATION: CLIPS DO NOT CLOSE / NO HOLD ON THE CLAMP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 24-FEB-2022: THERE WAS NO PATIENT INJURY. 3 CLIPS WERE TRIED ON THE PATIENT. THE ISSUE WAS RESOLVED BY TAKING ANOTHER LOT. THE CLIPS ARE AVAILABLE FOR RETURN. THE SINGLE-USED DEVICES WERE NOT REUSED, THEY USED OTHER CLIPS OF THE SAME LOT. TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13846924 ↗
• MalfunctionMar 22, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: LES CLIPS NE FERMENT PAS /PAS DE MAINTIEN DE LA PRISE. TRANSLATION: CLIPS DO NOT CLOSE / NO HOLD ON THE CLAMP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6)2022: THERE WAS NO PATIENT INJURY. 3 CLIPS WERE TRIED ON THE PATIENT. THE ISSUE WAS RESOLVED BY TAKING ANOTHER LOT. THE CLIPS ARE AVAILABLE FOR RETURN. THE SINGLE-USED DEVICES WERE NOT REUSED, THEY USED OTHER CLIPS OF THE SAME LOT. TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13846867 ↗
• MalfunctionFeb 19, 2020Difficult to Open or Close; Difficult to Open or Close

  THE CLIP REMAINED BLOCKED IN THE OPEN POSITION WHEN THE SURGEON WANTED TO CLAMP THE MAMMARY ARTERY. CLINICAL CONSEQUENCE: NONE. THIS INCIDENT TOOK PLACE AT THE CTCV BLOCK ON (B)(6) 2020 AND ON (B)(6) 2020. ORIGINAL : LE CLIP EST RESTÉ BLOQUÉ EN POSITION OUVERTE LORSQUE LE CHIRURGIEN A VOULU CLAMPER L'ARTÈRE MAMMAIRE. CONSÉQUENCE CLINIQUE : AUCUNE. CET INCIDENT A EU LIEU AU BLOC CTCV LE (B)(6) 2020 ET LE (B)(6) 2020. CLINICAL CONSEQUENCE: NONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9730048 ↗
• MalfunctionFeb 19, 2020Difficult to Open or Close; Difficult to Open or Close

  THE CLIP REMAINED BLOCKED IN THE OPEN POSITION WHEN THE SURGEON WANTED TO CLAMP THE MAMMARY ARTERY. CLINICAL CONSEQUENCE: NONE. THIS INCIDENT TOOK PLACE AT THE CTCV BLOCK ON (B)(6) 2020 AND ON (B)(6) 2020. ORIGINAL : LE CLIP EST RESTÉ BLOQUÉ EN POSITION OUVERTE LORSQUE LE CHIRURGIEN A VOULU CLAMPER L'ARTÈRE MAMMAIRE. CONSÉQUENCE CLINIQUE : AUCUNE. CET INCIDENT A EU LIEU AU BLOC CTCV LE (B)(6) 2020 ET LE (B)(6) 2020. CLINICAL CONSEQUENCE: NONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9730046 ↗