OptiSeal™ 1000093-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821329600203), received between Oct 19, 2017 and Dec 20, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT THE SHEATH DID NOT BREAK APPROPRIATELY. THE HARD CLEAR PLASTIC PIECE HAD BROKEN APART FROM THE TOP REAR PORTION OF THE LIGHT BLUE HANDLE (NOT THE CLEAR TUBING, BUT THE OTHER SMALL CLEAR PIECE WHERE LEAD ENTERS). THE LEAD HAD BEEN ATTACHED TO THIS HARD CLEAR PLASTIC AREA WHEN IT BROKE. THE BLUE HANDLE REMAINED IN ONE PIECE; IT DID NOT BREAK IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133057 ↗
• MalfunctionOct 19, 2017Material Separation; Material Separation

  AS REPORTED WHEN THE PHYSICIAN WENT TO SPLIT THE INTRODUCER, ONE OF THE ORANGE TABS BROKE OFF. INTRODUCER REMOVED USING SURGICAL INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962609 ↗