BioShield 00711129Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10816765013400), received between Aug 8, 2017 and Aug 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 8, 2017Disconnection

  THE BIOSHIELD® BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD® 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 A COLONOSCOPY PROCEDURE, THE BIOPSY VALVE CAME OFF THE ENDOSCOPE AND SPRAYED WATER CONTAINING BIOMATERIAL, SOME OF WHICH CONTACTED A NURSE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6773387 ↗