GYNECARE VERSAPOINT 00468Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031000797), received between Feb 28, 2018 and Jan 21, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K962482); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE ELECTRODE WAS USED. DURING SURGERY, THE ELECTRODE HEAD BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13321283 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED : GAS EMBOLISM DURING VERSAPOINT HYSTEROSCOPIC MYOMECTOMY. THIS IS A CASE REPORT CONCERNING A 40-YEAR-OLD WOMAN WITH MENORRHAGIA SECONDARY TO UTERINE FIBROIDS. DURING THE PROCEDURE, THE PATIENT WAS PLACED IN THE LITHOTOMY POSITION WITH SLIGHT HEAD-DOWN TILT (5-10°), AND THE CERVIX WAS DILATED WITH VERY LITTLE RESISTANCE TO BONNEY PARKER SIZE 8. A BAGGISH 8-MM THREE-CHANNEL OPERATING HYSTEROSCOPE WAS INSERTED THROUGH THE CERVIX INTO THE UTERINE CAVITY. SALINE WAS INSUFFLATED THROUGH A HYS-SURGIMAT HYSTEROFLATOR SET AT 250 ML MIN-1 AND INITIAL PRESSURE OF 75 MMHG. TO REDUCE FLUID ABSORPTION THE MAXIMUM INSUFFLATION PRESSURE WAS ADJUSTED ACCORDING TO THE MEAN ARTERIAL PRESSURE. FURTHER, HYSTEROSCOPIC VERSAPOINT SPRING (ETHICON) ENDOMETRIAL ABLATION AND SUBMUCOUS MYOMECTOMY WERE UNDER GENERAL ANAESTHETIC WITH SALINE AS THE DISTENSION MEDIUM. INTRAOPERATIVELY AN ACUTE AND PROFOUND DROP IN THE PATIENT'S END-TIDAL CARBON DIOXIDE AND OXYGEN SATURATION SUGGESTED OF GAS EMBOLISM, THE PROCEDURE WAS THEN ABANDONED WHICH THE PATIENT WAS TREATED WITH 100% OXYGEN. THE PATIENT WAS THEN TRANSFERRED TO THE RECOVERY WARD FOR 90 MIN. SHE REMAINED STABLE WI

  Patient problems: Embolism

  MAUDE report 9210102 ↗
• MalfunctionJul 12, 2019Material Deformation

  VERSAPOINT SPRING TIP CAUTERY WAS BEING USED BY DOCTOR. DURING USE DOCTOR SAID THAT HE NOTICED THE TIP NO LONGER LOOKED LIKE A SPRING, BUT A BALL AT THE END OF THE VERSAPOINT SPRING CAUTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784478 ↗
• MalfunctionFeb 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HYSTEROSCOPIC RESECTION OF MEDIASTINAL SEPTUM ON (B)(6) 2018 AND ELECTRODE WAS USED. THE PROCEDURE WAS FINISHED VERY SUCCESSFULLY. AFTER SURGERY, THE SURGEON FOUND THE ELECTRODE WAS BROKEN OFF, AND THE BROKEN PIECE WAS MISSING. THE PATIENT WAS CHECKED BY X RAY, BUT FOUND NOTHING. THE PATIENT IS STABLE AND LEFT THE HOSPITAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962482. One submission often covers many models, so check the product and lot details in each record.

• Z-0493-05 · Dec 16, 2004 · Terminated
  VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson