Symphion FG-0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729863656), received between Oct 12, 2017 and Oct 26, 2021 — classified as 1 death, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 13 most recent of 13 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 8, 2019Device Displays Incorrect Message; Pressure Problem; Device Displays Incorrect Message; Pressure Problem

  NOTE: 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)(4) 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 8769121 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A SYMPHION RESECTING DEVICE WAS USED DURING A HYSTEROSCOPY, DILATATION AND CURETTAGE PROCEDURE IN THE UTERUS PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, PERFORATION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Perforation

  MAUDE report 8461780 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2019 THAT A SYMPHION RESECTING DEVICE WAS USED DURING A HYSTEROSCOPY, DILATATION AND CURETTAGE, POLYPECTOMY PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UTERUS WAS PERFORATED WHILE RESECTING. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WERE NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Perforation

  MAUDE report 8317941 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION RESECTING DEVICE USED IN A HYSTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND INSIDE THE PATIENT, THE RESECTING DEVICE WAS USED TO DO AN ENDOMETRIAL SAMPLING AND NOTICED THAT THERE WAS A 400CC FLUID LOSS EARLY IN THE CASE. THE PHYSICIAN ADVANCED A LITTLE FURTHER WITH GOOD VISUALIZATION BUT AT SOME POINT THE DEFICIT JUMPED TO 800CC. UPON PROCEDURE CLOSURE, THE PHYSICIAN SUSPECTED PERFORATION AND A LEAK INTO THE ABDOMEN . A LAPAROSCOPY WAS DONE AND A HOLE WAS FOUND IN THE UTERUS WITH A LITTLE BIT OF FLUID IN THE CAVITY. THE PHYSICIAN STITCHED IT UP AND SUCTIONED ANY FLUID OUT FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN WAS UNSURE IF THE PERFORATION WAS CAUSED BY THE SYMPHION RESECTING DEVICE OR THE DILATION AT THE BEGINNING OF THE CASE. THE PROCEDURE WAS COMPLETED USING THIS 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: Uterine Perforation

  MAUDE report 7621710 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION RESECTING DEVICE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND INSIDE THE PATIENT, THE RESECTING DEVICE WAS USED TO REMOVE A FIBROID IN THE UTERUS AND THE PHYSICIAN NOTICED THAT THERE WAS FLUID DEFICIT RISING QUICKLY. THE PROCEDURE WAS STOPPED AND A FLUID DEFICIT OF 2000CC WAS NOTED. THE PHYSICIAN SUSPECTED PERFORATION BUT THE PATIENT'S FAMILY REFUSED TO DO ADDITIONAL LAPAROSCOPIC PROCEDURE. THE SUSPECTED PERFORATION WAS NOT CONFIRMED. ADDITIONALLY, THE FIBROID WAS RESECTED BUT HALF OF THE FIBROID WAS FREE FLOATING INSIDE THE PATIENT. THE FLOATING FIBROID WAS NOT RETRIEVED AND THE PATIENT IS EXPECTED FOR EVALUATION A MONTH AFTER THE PROCEDURE TO CHECK IF THE FIBROID WOULD NATURALLY PASS THROUGH OR A SECOND PROCEDURE IS REQUIRED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Uterine Perforation

  MAUDE report 7462351 ↗
• MalfunctionApr 25, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT A SYMPHION RESECTING DEVICE WAS OPENED TO BE USED IN A HYSTEROSCOPY/POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STAFF WAS WORRIED ABOUT THE STERILITY OF THE DEVICE BECAUSE THE STERILE PACKAGING DID NOT COMPLETELY TEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION RESECTING 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 7462316 ↗
• MalfunctionOct 12, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A SYMPHION RESECTING DEVICE WAS USED DURING A HYSTEROSCOPY POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE DURING PREPARATION, THE COVER OF THE ACTUAL DEVICE WAS ALREADY RIPPED AND COMPROMISED THE STERILITY OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMPHION RESECTING 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945226 ↗