BioGuard 00711780Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816765012772), received between Apr 10, 2018 and Dec 13, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE BIOGUARD AIR/WATER & SUCTION VALVE DEVICE BECAME DISASSEMBLED DURING USE, CAUSING A PORTION THE VALVE TO STRIKE A USER. NO INJURY WAS REPORTED, AND NO TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161294 ↗
• MalfunctionApr 26, 2018Break; Incomplete or Missing Packaging

  REFERENCE MEDWATCH 4900220000-2018-8007.

  Patient problems: No Patient Involvement

  MAUDE report 7466216 ↗
• MalfunctionApr 10, 2018Break

  THE BUTTON WAS PLACED ON THE SCOPE, IN THE USUAL FASHION, AND WHEN THE PHYSICIAN PUSHED THE SPRING-LOADED BUTTON, IT BROKE APART IN PIECES. THE STAFF REPORTED SEVERAL OTHER INSTANCES, HOWEVER IT WAS NOT BROUGHT TO MANAGEMENT'S ATTENTION UNTIL RECENTLY. THE STAFF HAVE DETERMINED, BASED ON PRODUCT PACKAGING, THE BUTTON WAS CONTAINED WITHIN THE VIA PROCEDURE KIT (#00719709). THE DEPARTMENT STOCKS ADDITIONAL BUTTONS, HOWEVER THEY COME TWO (BLUE AND RED) TO A PACKAGE WHERE THIS PACKAGE CONTAINS ONLY ONE (BLUE) BUTTON. THE KIT IS WRAPPED WHICH PREVENTS VISUAL INSPECTION OF ITS CONTENTS, SO THERE IS NO WAY TO DETERMINE WHICH KITS HAVE THIS PARTICULAR LOT NUMBER. THE STAFF HAVE BEEN ASKED TO RETAIN THE OUTER PACKAGE WRAP AS WELL TO TRACK KIT LOT NUMBERS TOO.

  Patient problems: No Information

  MAUDE report 7411335 ↗