GYNECARE VERSAPOINT 00467Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031000780), received between Jul 13, 2019 and Jun 15, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗

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