BioGuard 00711783Recalls & reported problems
US Endoscopy · The single use BioGuard air/water valve (3-piece) is used to control the air / water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of the gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port thought the endoscopic procedure and provides access for irrigation. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765012994), received between Aug 10, 2017 and Aug 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2017Device Operates Differently Than Expected
THE BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE USER FACILITY REPORTED DURING THE CLEANING PROCESS FOLLOWING A PROCEDURE THE LID OF THE BIOPSY VALVE OPENED AND SPRAYED THE TECHNICIAN WITH FLUID. THE TECH WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT AND DID NOT COME INTO CONTACT WITH THE FLUID. AS THE EVENT TOOK PLACE AFTER A PROCEDURE THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Code Available
MAUDE report 6784694 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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