GYNECARE VERSAPOINT 00466Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031000773), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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