COBLATOR II Flow Valve EA8002-00Recalls & reported problems
Smith & Nephew, Inc. · COBLATOR II FLOW CONTROL UNIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470002157), received between Sep 16, 2024 and Jun 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
- Excess Flow or Over-Infusion1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT, DURING A TONSILLECTOMY, THE WATER FLOW FROM ONE (1) FLOW CONTROL UNIT HAD NO CONTROL. THE WATER WAS FLOWING DURING THE CASE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547138 ↗MalfunctionSep 8, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE FLOW CONTROL UNIT WAS NOT RESPONDING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994200 ↗MalfunctionSep 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SET UP, THE IRRIGATION PUMP TUBE FEEDER BUTTON OF THE FLOW CONTROL UNIT WAS GETTING STICKY. THE STAFF REPORTED STRUGGLING TO GET THE IRRIGATION FLOW TO STOP BUT DID NOT HAVE AN ISSUE WITH A DIFFERENT PUMP. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20232843 ↗
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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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