Symphion FG-0612-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729897279), received between Aug 10, 2018 and Nov 5, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 10, 2018Electrical /Electronic Property Problem; Device-Device Incompatibility; Electrical /Electronic Property Problem; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION CONTROLLER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE SYMPHION RESECTING DEVICE STARTED RESECTING IMMEDIATELY AFTER CONNECTING IT INTO THE SYMPHION CONTROLLER. THE RESECTING DEVICE WAS INSERTED THROUGH THE ENDOSCOPE WHILE THE RESECTING DEVICE WAS ACTIVATED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS 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 7773671 ↗
• MalfunctionAug 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A SYMPHION CONTROLLER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE SYMPHION RESECTING DEVICE STARTED RESECTING IMMEDIATELY AFTER CONNECTING IT INTO THE SYMPHION CONTROLLER. THE RESECTING DEVICE WAS INSERTED THROUGH THE ENDOSCOPE WHILE THE RESECTING DEVICE WAS ACTIVATED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS 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 7773665 ↗