GYNECARE VERSAPOINTRecalls & reported problems across all models

We found 5 models of GYNECARE VERSAPOINT by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2018 and May 31, 2023 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GYNECARE VERSAPOINT problems

GYNECARE VERSAPOINT models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GYNECARE VERSAPOINT 01985

  HYSTEROSCOPE (AND ACCESSORIES)
  14 reports
• GYNECARE VERSAPOINT 00467

  HYSTEROSCOPE (AND ACCESSORIES)
  5 reports
• GYNECARE VERSAPOINT 00468

  HYSTEROSCOPE (AND ACCESSORIES)
  4 reports
• GYNECARE VERSAPOINT 00466

  HYSTEROSCOPE (AND ACCESSORIES)
  1 report
• GYNECARE VERSAPOINT 01939

  HYSTEROSCOPE (AND ACCESSORIES)
  1 report

Recent GYNECARE VERSAPOINT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionJun 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY ON AN UNKNOWN DATE IN (B)(6) 2021 AND THE ELECTRODE WAS USED. PRIOR TO THE PROCEDURE IT WAS FOUND THAT A PIECE OF METAL AT THE END OF THE ELECTRODE WAS NOT TIGHT ENOUGH AND UNABLE TO INSERT INTO THE CABLE. UPON EVALUATION OF THE RETURN SAMPLE IT WAS FOUND THAT A PIECE OF THE ELECTRODE HAD BROKEN OFF. IT WAS REPORTED THAT THE CASE WAS COMPLETED WITH ANOTHER ELECTRODE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING. THE EVENT DID NOT OCCUR DURING FIELD INSPECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005960 ↗
• 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 ↗
• MalfunctionDec 8, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON (B)(6) 2020 AND AN ELECTRODE WAS USED. IT WAS REPORTED THAT AT THE OPENING THERE WAS A BENT HOOK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969345 ↗
• 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 ↗
• 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 24, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO USE OF THE ELECTROSURGICAL/ELECTRODE DEVICE IN THE UNKNOWN PROCEDURE ON THE PATIENT, THE PACKAGE WAS CRACKING; THE RUPTURE OCCURRED IN THE PRIMARY PACKAGING. AS REPORTED, THIS ISSUE WAS NEVER HAPPENED BEFORE. IT WAS DETECTED UPON RECEIPT OF THE DEVICE BY THE DISTRIBUTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824035 ↗
• MalfunctionJul 24, 2019Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE ELECTROSURGICAL/ELECTRODE DEVICE IN THE UNKNOWN PROCEDURE ON THE PATIENT, THE PACKAGE WAS CRACKING; THE RUPTURE OCCURRED IN THE PRIMARY PACKAGING. AS REPORTED, THIS ISSUE WAS NEVER HAPPENED BEFORE. IT WAS DETECTED UPON RECEIPT OF THE DEVICE BY THE DISTRIBUTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823999 ↗
• MalfunctionJul 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE ELECTROSURGICAL DEVICE WAS USED. IT WAS DETECTED THAT THE PRODUCT PACKAGING IS CRACKING EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787372 ↗
• MalfunctionJul 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE ELECTROSURGICAL DEVICE WAS USED. IT WAS DETECTED THAT THE PRODUCT PACKAGING IS CRACKING EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787370 ↗
• 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 ↗

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