Symphion Resecting Device FG-0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850033976076), received between Oct 23, 2024 and Sep 16, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Detachment of Device or Device Component

  It was reported that the physician had completed the resection and was removing the device from the patient when it was discovered that the device had detached into two pieces. The physician successfully retrieved the detached tip from the patient. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792416 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 50241948 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN ENTERED THE CAVITY WITH THE SYMPHION SCOPE. NAVIGATION THROUGH THE CERVIX WAS DIFFICULT DUE TO SUSPECTED CANCEROUS TUMORS, AND THE PHYSICIAN WAS UNABLE TO IDENTIFY INTERNAL UTERINE LANDMARKS. SHORTLY AFTER THE SCOPE INTRODUCTION, THE SYMPHION RESECTING DEVICE WAS OPENED AND INTRODUCED. THE PHYSICIAN WAS ABLE TO CLEAN CERTAIN PARTS OF THE CAVITY AFTER ENTERING AND EXITING THE UTERINE CAVITY MULTIPLE TIMES. DURING REPEATED DEVICE ENTRY AND EXIT, A PERFORATION NEAR THE FUNDUS WAS OBSERVED. THE PROCEDURE WAS ABORTED, AND THE LAPAROSCOPY PROCEDURE WAS PERFORMED TO STOP THE BLEEDING. REPORTEDLY, THE PATIENT WAS STABLE AND DOING FINE AFTER SURGERY. NO FURTHER MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 25818740 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY HAD A NOVASURE ABLATION AND HAD A LOT OF SCAR TISSUE THAT MADE IT TOUGH TO NAVIGATE THROUGH THE CERVIX WHILE THE PHYSICIAN WAS PERFORMING ULTRASOUND-GUIDED HYSTEROSCOPY AND POLYPECTOMY USING THE SYMPHION SYSTEM. TO GAIN ACCESS THROUGH THE CERVIX, THE PHYSICIAN REQUIRED MULTIPLE INSTRUMENTS, INCLUDING A UTERINE SOUND AND SEVERAL DILATORS. THE SYMPHION SCOPE WAS INSERTED, AND MINIMAL RESECTION WAS REQUIRED TO RESECT THE SMALL POLYP. THE PRESSURE RELIEF VALVE (PRV) OPENED; HOWEVER, THE RESECTION WAS DEEMED COMPLETED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR ISSUES DURING RESECTION. IN THE RECOVERY UNIT, THE PATIENT REPORTED SEVERE ABDOMINAL PAIN AND WAS RETURNED TO THE OPERATING ROOM A FEW HOURS POST-PROCEDURE. THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPY AND DISCOVERED COAGULATED BLOOD IN THE ABDOMEN. SUCTION AND IRRIGATION WERE PERFORMED TO CLEAR THE BLOOD. NO ACTIVE BLEEDING SOURCE WAS IDENTIFIED. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND WENT HOME THE NEXT DAY.

  Patient problems: Hematoma

  MAUDE report 25636898 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SYMPHION OPERATIVE HYSTEROSCOPY FOR A MYOMECTOMY PROCEDURE ON (B)(6) 2026, AFTER 30 MINUTES OF RESECTION, THE SYSTEM ALERTED TO REPLACE THE FIRST DEVICE. DURING RESECTION USING A SECOND DEVICE, THE SALES REPRESENTATIVE NOTICED AN INCREASE IN BLEEDING AND FLUID DEFICIT. SHE POINTED THIS OUT TO THE PHYSICIAN AND ASKED WHETHER THE PHYSICIAN STILL HAD VISIBILITY; OTHERWISE, SHE SHOULD NOT PROCEED. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. ON (B)(6) 2026, THE REPRESENTATIVE WAS INFORMED BY OTHER PHYSICIANS THAT THERE WAS A PERFORATION, AND EITHER LATE THAT NIGHT OR THE NEXT DAY, THE PATIENT HAD TO GO BACK TO THE HOSPITAL, SPEND SOME TIME THERE FOR AN ADDITIONAL PROCEDURE RELATED TO BLOOD IN THE ABDOMEN. THE PATIENT WAS RELEASED (DATE UNKNOWN) AND IS DOING OK. ON (B)(6) 2026, DURING A FOLLOW-UP, THE TREATING PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL NOW AND SHE HAS NO CONCERNS. THE DOCTOR DID TREAT THE PATIENT FOR THE PERFORATION BUT WAS NOT WILLING TO GO INTO DETAILS ABOUT WHAT WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 24651324 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A D&C AND SYMPHION PROCEDURE IN A NULLIPAROUS, POSTMENOPAUSAL PATIENT SUFFERING FROM AUB (L). THE CERVIX WAS EXTREMELY SMALL, AND THE PHYSICIAN SPENT AN HOUR TO ACHIEVE THE DILATION FOR THE SYMPHION HYSTEROSCOPE INSERTION. NO CLEAR VISUALIZATION WAS ACHIEVED, AND THE PHYSICIAN WAS NOT SURE WHERE EXACTLY IN THE UTERINE CAVITY SHE WAS LOCATED. DESPITE ALL EFFORTS, A CLEAR VISUALIZATION WAS NEVER ESTABLISHED, AND THE BLEEDING SOURCE WAS NOT IDENTIFIABLE HYSTEROSCOPICALLY. AT SOME POINT, THE DISTENTION MEDIA BAG BECAME EMPTY, AND DR. AKIN REQUESTED THAT A SECOND BAG BE CONNECTED. DESPITE THE AXORA REPRESENTATIVE'S ADVICE, THE SECOND BAG WAS CONNECTED AND USED. UNSUCCESSFUL ATTEMPTS WERE MADE TO CLEAR THE VIEW, SO THE PHYSICIAN DECIDED TO REMOVE THE RESECTING DEVICE (RD). WHILE WITHDRAWING THE DEVICE, THE PHYSICIAN NOTED THAT THE RD TIP DID NOT MOVE. SHE PRUDENTLY DECIDED TO WITHDRAW THE HYSTEROSCOPE, AND THE TIP OF THE RD CAME WITH IT, OUT TO THE VAGINA, AND WAS TAKEN OUT FROM THE CAVITY. DUE TO CONTINUOUS AND PROFUSE BLEEDING, THE PHYSICIAN ELECTED TO PERFORM A HYSTERECTOMY DURING WHICH A UTERINE PERFORATION AT THE FUNDUS OF THE UTERUS, NEX

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 24537320 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SYMPHION PROCEDURE, WHILE RESECTING THE 3CM UTERINE FIBROID, THE PHYSICIAN HIT AN ARTERY OR VESSEL AND COULD NOT SEE OR CONTINUE THE CASE. THE PATIENT'S BLOOD LOSS WAS 350 ML, AND THE PATIENT WAS TAKEN TO THE ICU. THE PATIENT REPORTEDLY RECOVERED AND WENT HOME THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 24485388 ↗
• MalfunctionFeb 9, 2026

  DURING THE SURGERY, THE HANDLE OF THE SYMPHION RESECTION DEVICE SNAPPED AT THE HANDLE. THE BROKEN PIECE REMAINED SEPARATE FROM THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290784 ↗
• InjuryOct 23, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED A LARGE FIBROID WAS PRESENT IN THE UTERINE CAVITY AND THE PHYSICIAN WAS ATTEMPTING RESECTION WITH THE SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM, RESECTING DEVICE. THE PATIENT WAS NOTED TO HAVE PATULOUS CERVIX. DURING THE RESECTION, IT WAS OBSERVED APPROXIMATELY 3 LITERS OF FLUID LEAKED FROM THE PATIENT INTO THE OUTFLOW BAG AND MULTIPLE BAGS OF SALINE WERE USED IN THIS CASE, WHICH WAS IN CONFLICT WITH THE MINERVA SURGICAL'S SALES REPRESENTATIVE'S RECOMMENDATION AND DEVICE LABELLING. THE EXACT NUMBER OF 3L SALINE BAGS USED DURING THE PROCEDURE IS UNKNOWN. POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WHERE TWO PERFORATIONS OF THE UTERUS AND ONE PERFORATION OF THE RECTUM WERE IDENTIFIED. THE PATIENT WAS SEPTIC AND REQUIRED ADDITIONAL INTERVENTION.

  Patient problems: Perforation; Sepsis; Uterine Perforation

  MAUDE report 20519117 ↗