VIA 00719701Recalls & reported problems
US Endoscopy · The VIA Compliance Kit includes Basin, Sponge, (10) Gauze Pads, Biohazard Sticker, Transport Pad, 2 Oz. Lube Tube, Double Header Brush. · Class 2
Data updated Oct 13, 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 00816765012390), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2018Entrapment of Device; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE BRUSH HEAD OF A DOUBLE-HEADER CLEANING BRUSH BECAME DETACHED DURING CLEANING AND WAS RETAINED IN THE ENDOSCOPE ACCESSORY CHANNEL. THE BRUSH HEAD WAS PUSHED INTO THE PATIENT DURING THE NEXT PROCEDURE. THE PHYSICIAN CHOSE NOT TO RETRIEVE THE BRUSH HEAD, INSTEAD ALLOWING IT TO PASS NATURALLY. THERE WAS NO REPORTED HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 8073345 ↗
Other Endoscope introducer kit devices
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- Medline Industries, Inc. DYNJ66447Medline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ58648JMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- CARDINAL HEALTH SBA73CLKFDCardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- Medline Industries, Inc. DYKE1355Medline Industries, Inc. · Endoscope introducer kit1 recall0 reports
- Medline Industries, Inc. DYNJ60126BMedline Industries, Inc. · Endoscope introducer kit1 recall0 reports
- Medline Industries, Inc. DYK1012268E1Medline Industries, Inc. · Endoscope introducer kit1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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