GYNECARE VERSAPOINT 01985Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031001008), received between Mar 14, 2018 and May 31, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND AN ELECTROSURGICAL DEVICE WAS USED. DURING THE SURGERY, THE ELECTROSURGICAL RING BROKE AND FELL INTO THE PATIENT'S BODY. THE DOCTOR IMMEDIATELY STOPPED THE SURGERY AND FOUND THE OBJECT THAT FELL INTO THE BODY, AND REPLACED IT WITH A NEW ELECTROSURGICAL RING FOR NORMAL SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032020 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPIC REMOVAL OF INTRAUTERINE PREGNANCY + SUBMUCOSAL MYOMECTOMY PROCEDURE ON (B)(6) 2023 AND AN ELECTROSURGICAL DEVICE WAS USED. DURING THE SURGERY, THE ELECTROSURGICAL RING FELL OFF, AND THE DETACHED OBJECT WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW INSTRUMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946207 ↗
• MalfunctionDec 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESECTION OF A SUBMUCOUS MYOMA OF THE UTERUS PROCEDURE ON (B)(6) 2022 AND AN ELECTROSURGICAL DEVICE WAS USED. DURING THE SURGERY, THE DOCTOR FOUND THAT THE ELECTROSURGICAL RING WAS BROKEN, AND REPEATEDLY SEARCHED FOR THE ELECTROSURGICAL RING THAT WAS NOT BROKEN IN THE UTERINE CAVITY. THE BREAKAGE OF THE PRODUCT DURING THE SURGERY AFFECTED THE SURGERY AND INCREASED THE SURGERY TIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15920846 ↗
• MalfunctionMay 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ELECTROSURGICAL GYNECOLOGICAL PROCEDURE ON (B)(6) 2020 AND THE DEVICE DID NOT WORK. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812448 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROSURGICAL PROCEDURE ON (B)(6) 2020 AND AN ELECTRODE WAS USED. THE BIPOLAR ELECTRODE HAD A BREAK IN THE SEALING RUBBER CAUSING A LOT OF LEAKAGE. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10616593 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTEROSCOPIC VIDEO MYOMECTOMY ON (B)(6) 2019 AND THE ELECTROSURGICAL DEVICE WAS USED. IT WAS REPORTED THAT THE BIPOLAR LOOP BROKE DUE TO THE LARGE MYOMA BEING HARDENED/CALCIFIED BEFORE COMPLETE RESECTION. IT WAS NECESSARY TO USE ANOTHER LIKE LOOP TO FINISH THE MYOMECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9792445 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE ELECTROSURGICAL DEVICE WAS USED. DURING THE PROCEDURE, LOOP SPLIT. THE PROCEDURE COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733378 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTEROSCOPY ON (B)(6) 2019 AND THE ELECTROSURGICAL DEVICE WAS USED. IT WAS ALSO REPORTED THAT HAND LOOP BROKE DURING THE SURGICAL PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359872 ↗
• MalfunctionFeb 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOMETRIAL RESECTION ON (B)(6) 2019. DURING THE PROCEDURE, THE LOOP FELL OFF AND WAS RETRIEVED FROM THE PATIENT. A NEW LOOP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344128 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON (B)(6) 2018 AND THE ELECTROSURGICAL DEVICE WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED. DURING THE EVALUATION, THE ACTIVE TIP ON THE RETURNED DEVICE WAS FOUND TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251660 ↗
• MalfunctionDec 31, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON (B)(6) 2018 AND THE ELECTROSURGICAL DEVICE WAS USED. IT WAS ALSO REPORTED THAT THE DEVICE BROKE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206085 ↗
• MalfunctionApr 25, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MYOMECTOMY ON (B)(6) 2017. DURING THE PROCEDURE, IT WAS REPORTED THAT THE HANDLE BROKE AFTER IT WAS TRIGGERED. UPON DEVICE EVALUATION, THE LOOP WAS FOUND BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7462236 ↗
• MalfunctionApr 3, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTECTOMY ON (B)(6) 2018. DURING THE PROCEDURE, THE STRAP BROKE DURING USE. IT WAS REPORTED THAT NO PART OF THE BROKEN PART FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393447 ↗
• MalfunctionMar 14, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HYSTEROSCOPY ON (B)(6) 2018. DURING THE PROCEDURE, THE STRAP BROKE IN THE MIDDLE OF THE PROCEDURE. A SIMILAR PRODUCT WAS USED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339782 ↗