Symphion FG-0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729863717), received between Nov 22, 2016 and Nov 20, 2020 — classified as 1 death, 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SYMPHION CONTROLLER UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, A LINE CLOGGED DURING A CASE SO THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10874856 ↗
• InjuryDec 18, 2019Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 26, 2019 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS USED IN A HYSTEROSCOPY WITH MYOMECTOMY PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN WAS RESECTING A VERY LARGE FIBROID WHEN THE TISSUE SACK BECAME FULL. WHEN THEY CHANGED THE FLUID MANAGEMENT KIT IT WOULD NOT PRIME. REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE RISK OF EMBOLISM. IN THE PHYSICIANS ASSESSMENT AIR WAS PUSH INTO THE PATIENT'S BLOOD VESSELS WHEN THE FLUID MANAGEMENT KIT WAS SWITCHED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. AS OF (B)(6) 2019, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Air Embolism; No Code Available

  MAUDE report 9488718 ↗
• DeathAug 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO SYMPHION RESECTING DEVICE THAT WERE USED N THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO SYMPHION RESECTING DEVICES WERE USED IN A HYSTEROSCOPY WITH DILATATION AND CURRETAGE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PROCEDURE STARTED NORMALLY. DURING HYSTEROSCOPY, THE PHYSICIAN NOTED THAT THERE WAS A PATHOLOGY IN THE UTERINE CAVITY. THE PHYSICIAN USED RESECTING DEVICE AND ABOUT 2 TO 3 MINUTES OF RESECTION, THE SYMPHION SYSTEM ALARMED "CHECK THE SYSTEM FOR LEAK". REPORTEDLY, THERE WAS NO FLUID COMING OUT OF THE CERVIX AND THE PATIENT WAS LOSING FLUID AT A FASTER RATE THAN NORMAL. DURING THIS TIME, THE VISUALIZATION OF THE CAVITY WAS IMPAIRED AND IT WAS RECOMMENDED TO STOP THE PROCEDURE. THE PROCEDURE WAS ABORTED AND THE TOTAL FLUID DEFICIT WAS 700 ML. THE VITAL SIGNS OF THE PATIENT WERE STABLE AT THE TIME THE PROCEDURE WAS ABORTED. SEVERAL DAYS POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT WENT BACK TO THE HOSPITAL DUE TO A PERFORATION. THE PATIENT UNDERWENT MULTIPLE SURGERIES AND DIED DUE TO SEPSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EV

  Patient problems: Death; Perforation; Sepsis

  MAUDE report 8865424 ↗
• MalfunctionMar 18, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS TO BE FOR A HYSTEROSCOPY WITH DILATATION AND CURETTAGE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PACKAGING WAS CRACKED AND THE DEVICE WAS UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT ACCESSORY. THERE WERE NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427921 ↗
• MalfunctionFeb 7, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS USED DURING A HYSTEROSCOPY WITH DILATATION AND CURETTAGE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PLASTIC TRAY WAS CRACKED AND THE STERILE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT ACCESSORY. THERE WERE NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317517 ↗
• MalfunctionNov 1, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS CHECKED DURING AN INVENTORY ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING INVENTORY, THE SYMPHION FLUID MANAGEMENT ACCESSORY WAS PULLED OUT FROM THE SHELF AND IT WAS NOTED THAT THE CLEAR STERILE PACKAGE OF THE DEVICE HAD A CRACK ON THE RIGHT CORNER.

  Patient problems: No Patient Involvement

  MAUDE report 8030486 ↗
• MalfunctionNov 1, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS USED DURING A HYSTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CLEAR STERILE PACKAGE OF THE DEVICE HAD A CRACK ON THE RIGHT CORNER. THERE WAS NO DAMAGE NOTED ON THE DEVICE INSIDE BUT IT WAS SUSPECTED THAT IT MIGHT BE UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT ACCESSORY. THERE WERE NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8030477 ↗
• MalfunctionJun 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY WAS USED IN A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT DURING PREPARATION, THE TUBE CONNECTING THE ASPIRATION PUMP AND TISSUE CATCH WAS LOOSE AND BURST OPEN WHEN THE PHYSICIAN STARTED TO RESECT. THE PHYSICIAN AND OR STAFF DID NOT WEAR SPECIFIC OR GOGGLES FOR EYE PROTECTION WHEN IT HAPPENED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7595656 ↗
• MalfunctionMay 3, 2018Contamination; Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS OPENED TO BE USED IN A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE PRESSURE SENSOR FELL OFF THE GROUND AND BECAME UNSTERILE WHEN THE PHYSICIAN WAS ABOUT TO ADVANCE THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483872 ↗
• MalfunctionApr 25, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS OPENED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE INTRODUCER FROM FLUID MANAGEMENT ACCESSORY WAS NOT PACKAGE PROPERLY, IT POPPED OUT AND BECAME UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7462339 ↗
• MalfunctionJan 16, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS OPENED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STERILE SEAL WAS ALREADY BROKEN WHEN THE DEVICE WAS REMOVED FROM THE BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION RESECTING DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7192895 ↗
• MalfunctionSep 21, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THEY GOT AN ERROR MESSAGE "PRESSURE SENSOR FAILED". THEY TRIED TO DISCONNECT AND RECONNECT THE DEVICE BUT STILL GOT THE SAME ERROR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6882151 ↗
• MalfunctionSep 21, 2017Device Inoperable; Device Inoperable

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-02791 PERTAINS TO THE FIRST SYMPHION FLUID MANAGEMENT ACCESSORY AND MANUFACTURER REPORT # 3005099803-2017-02792 TO THE SECOND SYMPHION MANAGEMENT ACCESSORY. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY RECEIVED A FAULTY PRESSURE SENSOR ERROR MESSAGE (CAPTURED IN MFR REPORT # 3005099803-2017-02791). A SECOND FLUID MANAGEMENT ACCESSORY DEVICE WAS USED BUT THE SAME THING HAPPENED (CAPTURED IN MFR REPORT # 3005099803-2017-02792) .THE PROCEDURE WAS COMPLETED WITH A THIRD SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6882028 ↗
• MalfunctionSep 14, 2017Device Inoperable; Device Inoperable

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-02791 PERTAINS TO THE FIRST SYMPHION FLUID MANAGEMENT ACCESSORY AND MANUFACTURER REPORT # 3005099803-2017-02792 TO THE SECOND SYMPHION MANAGEMENT ACCESSORY. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY RECEIVED A FAULTY PRESSURE SENSOR ERROR MESSAGE (CAPTURED IN MFR REPORT # 3005099803-2017-02791). A SECOND FLUID MANAGEMENT ACCESSORY DEVICE WAS USED BUT THE SAME THING HAPPENED (CAPTURED IN MFR REPORT # 3005099803-2017-02792) . THE PROCEDURE WAS COMPLETED WITH A THIRD SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866256 ↗
• MalfunctionSep 14, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED DURING A HYSTEROSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY HIT THE OKAY BUTTON TO TEST THE PRESSURE SENSOR, THEY KEPT RECEIVING "PRESSURE SENSOR FAILURE, REPLACE PRESSURE SENSOR" ERROR MESSAGE. THEY TRIED TO UNPLUG AND PLUGGING IT BACK IN AND KEPT ON GOING TO THE PROCESS HOWEVER, IT WOULD SHOW THAT THE PRESSURE SENSOR FAILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6865371 ↗
• MalfunctionAug 29, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A SYMPHION MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CONTROLLER KEPT ON PROMPTING A "REPLACE SENSOR" MESSAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827365 ↗
• MalfunctionAug 29, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED DURING A HYSTEROSCOPY POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING SET-UP, THE PRESSURE SENSOR FAILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826483 ↗
• MalfunctionAug 23, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING SET-UP, THEY RECEIVED A FAULTY PRESSURE SENSOR ALARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812772 ↗
• MalfunctionAug 22, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A HYSTEROSCOPIC MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY RECEIVED A FAULTY PRESSURE SENSOR ERROR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION FLUID MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811156 ↗
• MalfunctionAug 9, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A HYSTERSOCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY GOT PRESSURE SENSOR FAILED AFTER PLUGGING IN THE KIT. THEY TRIED TO DISCONNECT AND RECONNECT THE DEVICE AS WELL AS TURNING IT ON AND OFF BUT THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776367 ↗
• MalfunctionAug 9, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED IN A HYSTEROSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY GOT A PRESSURE SENSOR FAIL MESSAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLUID MANAGEMENT ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776352 ↗
• MalfunctionAug 9, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED IN A HYSTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY PLUGGED THE PRESSURE SENSOR INTO THE CONSOLE, THE CONTROLLER PROMPTED A FAULTY PRESSURE SENSOR MESSAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLUID MANAGEMENT ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776346 ↗
• MalfunctionAug 9, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A HYSTEROSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING SET-UP, THE CONSOLE PROMPTED "PRESSURE SENSOR FAILED". THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776341 ↗
• MalfunctionJul 18, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORY DEVICE WAS USED IN A SYMPHION RESECTION PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CONTROLLER PROMPTED A FAULTY PRESSURE SENSOR MESSAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLUID MANAGEMENT ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722720 ↗
• MalfunctionJul 18, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION FLUID MANAGEMENT ACCESSORIES DEVICE WAS USED DURING A HYSTEROSCOPY, DILATATION AND CURETTAGE WITH SYMPHION PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING SET-UP, THE CONSOLE NOTIFIED "PRESSURE SENSOR FAILED". THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION MANAGEMENT KIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6721939 ↗