SymphionRecalls & reported problems across all models

We found 4 models of Symphion by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Oct 26, 2021 — classified as 2 deaths, 9 injuries, 48 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Symphion problems

Symphion models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Symphion FG-0202

  Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
  1 death38 reports
• Symphion FG-0201

  Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
  1 death13 reports
• Symphion FG-0612-R

  Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
  7 reports
• Symphion FG-0612

  Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
  1 report

Recent Symphion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMPHION POLYPECTOMY WAS PERFORMED BY AN OB/GYN RESIDENT. THE CASE ACCORDING TO THE REPORT WAS CHALLENGING (DETAILS UNKNOWN). AT THE TIME OF HYSTEROSCOPE INSERTION, IT WAS REPORTED THAT THE USER SAW (BASED ON DESCRIPTION) SYNECHIA TYPE TISSUE AND DECIDED TO "CLEAN" THE CAVITY. AFTER ABOUT 5 MINUTES OF "CLEANING" A UTERINE PERFORATION WAS SUSPECTED, BASED ON SUDDEN LOSS OF FLUID AND VISUALIZATION OF THE ORGANS OF THE ABDOMINAL CAVITY. THE CASE WAS ABORTED.

  Patient problems: Uterine Perforation

  MAUDE report 12701544 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS MADE AWARE THAT A HYSTEROSCOPIC POLYPECTOMY USING THE SYMPHION SYSTEM WAS PERFORMED. DURING THE OTHERWISE UNEVENTFUL PROCEDURE, DOCTOR NOTICED A SUDDEN LOSS OF FLUID TOTALING APPROXIMATELY 700CC. AT THAT TIME THE POLYPECTOMY HAD BEEN COMPLETED. DOCTOR SUSPECTED A UTERINE PERFORATION AND POSSIBLE BLADDER PERFORATION. NONE WERE SUBSEQUENTLY CONFIRMED. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12524005 ↗
• 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 ↗
• MalfunctionNov 12, 2020Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESECTING DEVICE FAILED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830578 ↗
• MalfunctionNov 12, 2020Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESECTING DEVICE FAILED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830523 ↗
• MalfunctionNov 5, 2020Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; 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, THE UNIT HAD A PRESSURE SENSOR ERROR AND WAS USED IN A PROCEDURE BOTH IN THE MORNING AND IN THE AFTERNOON. A SECOND UNIT WAS USED BUT RECEIVED THE SAME ERROR 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 10793568 ↗
• MalfunctionSep 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SYMPHION CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE UNIT HAD BURNING SMELL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10553108 ↗
• MalfunctionSep 18, 2020Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SYMPHION CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE UNIT WAS LEAKING FLUID. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10553107 ↗
• MalfunctionJan 9, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A SYMPHION CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE RESECTING DEVICE WAS NOTED TO BE ACTIVATING ON IT'S OWN WITHOUT THE FOOT PEDAL BEING PRESSED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570324 ↗
• 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 ↗
• MalfunctionNov 19, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A SYMPHION CONTROLLER WAS USED IN A DILATION AND CURETTAGE (D AND C) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN THEY PLUGGED IN THE RESECTING DEVICE INTO THE CONTROLLER THE DEVICE STARTED RESECTING AND RECIPROCATING ON ITS OWN. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WERE NO PATIENT SAFETY ISSUES REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9342008 ↗
• MalfunctionNov 19, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 4, 2019 THAT A SYMPHION CONTROLLER WAS USED IN A DILATION AND CURETTAGE (D AND C) PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, WHEN THEY PLUGGED IN THE RESECTING DEVICE INTO THE CONTROLLER THE DEVICE STARTED RESECTING AND RECIPROCATING ON ITS OWN. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WERE NO PATIENT SAFETY ISSUES REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341891 ↗
• DeathAug 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO SYMPHION RESECTING DEVICE THAT WERE USED IN 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 CURETTAGE 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 E

  Patient problems: Death; Perforation; Sepsis

  MAUDE report 8865455 ↗
• 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 ↗
• InjuryJul 8, 2019Device Displays Incorrect Message; Pressure Problem; Device Displays Incorrect Message; Pressure Problem

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO SYMPHION RESECTING DEVICES THAT WERE USED ON THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO SYMPHION RESECTING DEVICE WAS USED FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ERROR WAS RECEIVED STATING LOW PRESSURE DETECTED, RESECTION ON HOLD AND IT WAS NOTED THAT THERE WAS SALINE LEAKING FROM THE PATIENT. THE DEVICE WAS CHANGED TO ANOTHER SYMPHION RESECTING DEVICE SINCE IT WAS THOUGHT THAT THERE WAS A DEVICE MALFUNCTION DUE TO THE ERROR. THE SECOND DEVICE WAS USED AND THERE WAS MORE SALINE NOTED THAT WAS FLOWING OUT FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RESECT, HOWEVER IT WAS NOTED THAT THERE LESS RETURN FLOW OF SALINE AND THERE WAS A TOTAL DEFICIT OF 2,200 ML. A LAPAROSCOPY PROCEDURE WAS NEEDED AND IT REVEALED A LOT OF SALINE WAS IN THE BELLY OF THE PATIENT. THE PHYSICIAN SUSPECTED POSSIBLE PERFORATION BUT SUCCESSFULLY COMPLETED THE PROCEDURE AFTER THE SALINE IN THE BELLY WAS REMOVED.

  Patient problems: Perforation

  MAUDE report 8769212 ↗

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