PAS-PORT FC700SURecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04046955241026), received between Mar 7, 2021 and Jun 15, 2021 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE STAPLES WERE DEPLOYED OUTSIDE OF THE AORTA. AFTER THE ANASTOMOSIS, THE STAPLES WAS DEPLOYED OUTSIDE THE AORTA AND ONLY LEFT A HOLE IN THE AORTA. A SIDE CLAMP WAS USED ON THE AORTA AND THE HOLE WAS CLOSED BY HAND SEWING. IT IS NOT CURRENTLY KNOWN HOW THE CASE WAS COMPLETED. THE NURSE THREW AWAY THE PPS BODY WITH THE SAPHENOUS VEIN GRAFT (SVG) INSIDE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004473 ↗
• InjuryMay 14, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING AN OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PASPORT SYSTEM WAS USED, HOWEVER, AFTER ROTATING THE KNOB, ONLY A HOLE WAS MADE IN THE AORTA AND BLEEDING OCCURRED. THE SAPHENOUS VEIN GRAFT (SVG) WAS REMOVED FROM THE TIP OF PPS BADY, AND THEN THE PROCEDURE WAS COMPLETED USING THE SIDE CLAMP. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827452 ↗
• InjuryMay 5, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING AN ON PUMP BEATING PROCEDURE PERFORMED IN EARLY (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ROTATING THE DEVICE KNOB, ONLY A HOLE WAS MADE IN THE AORTA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780650 ↗
• InjuryMay 4, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE VEIN GRAFT CAME OFF FROM ANASTOMOSIS. IT WAS REPORTED THAT PASSPORT SYSTEM WAS USED FOR OPCAB. AFTER THE ANASTOMOSIS OF THE VEIN GRAFT TO THE AORTA WAS PERFORMED (KNOB ROTATION), THE VEIN GRAFT (SVG) CAME OFF FROM THE ANASTOMOTIC SITE AND CAUSED BLEEDING. THE BLEEDING OF HOLE BY PPS CUTTER WAS STOPPED WITH A FINGER, THEN SVG WAS ANASTOMOSED BY HAND SEWING USING A SIDE CLAMP TO COMPLETE THE PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769630 ↗
• InjuryMay 4, 2021Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING ROTATING THE KNOB OF THE DELIVERY SYSTEM TO FIRED THE STAPLE TO AORTA, SOME KIND OF A CHIP SUCH AS THE MATERIAL OF PPS CAME OFF THE DEVICE. AS THE CHIP MIGHT COME OFF THE KNOB OF THE DEVICE AND FELL ON THE DISTAL END OF THE HOUSING OF DELIVERY DEVICE, THE CHIP WAS EASY TO SEE AND RETRIEVED FROM THE POINT. THE ANASTOMOSIS ITSELF WITH USE OF THE PPS WAS COMPLETED WITHOUT ANY PROBLEM. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769163 ↗
• InjuryApr 12, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, NO ANASTOMOSIS COULD BE PERFORMED. IT WAS REPORTED THAT PPS WAS USED FOR OPCAB. BUT SINCE THE PPS BODY COULD NOT BE PULLED OUT AFTER THE ANASTOMOSIS, THE SURGEON CONFIRMED THE ROOT OF ANASTOMOSIS SITE WITH FORCEPS. AND PPS BODY WAS ABLE TO PULL OUT. HOWEVER, WHEN THE SURGEON SUBSEQUENTLY CONFIRMED THE ANASTOMOTIC SITE, BLEEDING OCCURRED WITH THE OUTER FLANGE WARPED UP BY ABOUT 45 ° TO 50 °. PROBABLY THE OUTER FLANGE AND INNER FLANGE STOPPED JUST BEFORE THE DETACHMENT. AFTER THAT REMOVED THE STAPLER AND SVG USING A SIDE CLAMP, AND PERFORMED A CENTRAL ANASTOMOSIS BY HAND-SEWN INTO THE HOLE MADE BY PPS. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Menstrual Irregularities; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653038 ↗
• InjuryMar 29, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU -PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, NO ANASTOMOSIS WAS ACHIEVED. SURGERY WAS STOPPED, SUTURE CONTINUED BY HAND. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585473 ↗
• InjuryMar 26, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING A OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE INNER FLANGE ONLY PARTIALLY DEPLOYED. REPORTED, AFTER THE KNOB WAS ROTATED, THE INNER FLANGE WAS ONLY PARTIALLY DEPLOYED AND ONLY A HOLE WAS MADE IN THE AORTA. HEART STRING WAS INSERTED INTO THE HOLE MADE BY PPS CUTTER AND ANASTOMOSIS WAS PERFORMED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED OR MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576140 ↗
• InjuryMar 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE KNOB DID NOT ROTATE ANY MORE. IT WAS REPORTED THAT PPS WAS USED FOR OPCAB, BUT AFTER THE KNOB WAS ROTATED, ONLY A HOLE WAS MADE IN THE AORTA. WHEN THE SURGEON CHECKED THE DEVICE, THE INNER FLANGE WAS OPENED DIAGONALLY, THE KNOB DID NOT ROTATE ANY MORE, NO MATTER HOW MUCH FORCE WAS APPLIED, IT WAS POSSIBLE TO ROTATE IT BACKWARDS, AND THE SVG COULD BE TAKEN OUT. HEART STRING WAS INSERTED INTO THE HOLE MADE BY PPS CUTTER AND ANASTOMOSIS WAS PERFORMED TO COMPLETE THE PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553361 ↗
• InjuryMar 19, 2021Product Quality Problem; Product Quality Problem

  NO CHANGES REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529952 ↗
• MalfunctionMar 19, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, NO ANASTOMOSIS WAS ACHIEVED. CLAMPS WERE NOT FORMED PROPERLY, NO ANASTOMOSIS WAS ACHIEVED. THE PROCEDURE WAS CANCELLED AND A NEW DEVICE WAS USED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527119 ↗
• InjuryMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INTIMA-HOOKS DO NOT FULLY ENGAGE. PASPORT HAS TO BE UNCOUPLED AND THE VEIN HAS TO BE REMOVED AND PUT INTO A SECOND PASPORT AGAIN. HAPPENED DURING SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495996 ↗
• InjuryMar 16, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION,THE HOLE WAS PUNCTURED IN THE AORTA BUT THE VEIN WAS NOT FIXED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11495292 ↗
• InjuryMar 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM PART # FC700SU WAS USED DURING A OFF-PUMP CORONARY ARTERY BYPASS OPCAB PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT SINCE THE STAPLES WERE NOT OPENED MORE THAN USUAL, SURGEON PLACED AN ADDITIONAL NEEDLE ON THE STAPLES AND PROCEEDED WITH THE PROCEDURE. THE SURGEON TURNED THE KNOB TO THE END, BUT THE OUTER FLANGE WAS NOT SEPARATED. AT THAT TIME, THE KNOB DID NOT MOVE, AND WHEN IT TURNED SEVERAL TIMES, THE DEVICE WAS ABLE TO REMOVE, PROBABLY BECAUSE SOME OF THE OUTER FLANGES WERE CUT OFF. AFTER THAT, WOOSING OCCURRED AND IT WAS STOPPED WITH 4 OR 5 ADDITIONAL NEEDLES, BUT THE OUTER FLANGE REMAINED UPRIGHT. THERE WERE NO COMPLICATIONS IN THE PATIENT AS OF (B)(6), 2021. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11457532 ↗
• InjuryMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP AG THAT A PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (PART # FC700SU) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, THE SURGICAL TECHNIQUE COULDN´T BE PERFORMED COMPLETELY. WHEN THE PASPORT WAS TRIGGERED, ONLY A CLICK WAS HEARD WHEN THE KNOB WAS TURNED. THE KNOB CANNOT BE ROTATED ANY FURTHER. THE AORTA IS PERFORATED, BUT THE ANASTOMOSIS IS NOT COMPLETELY PERFORMED. PASPORT INSTRUMENT WAS ACTUALLY DAMAGED IN ORDER TO EXTRACT THE VEIN. THE AORTA WAS CLAMPED OUT AND THE ANASTOMOSIS WAS SUTURED BY HAND. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL PATIENT INFORMATION WAS NOT MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455241 ↗
• InjuryMar 7, 2021Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU PAS PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PASPORT DIDN'T TRIGGER PROPERLY DURING SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426396 ↗