NA 8291102Recalls & reported problems
Richard Wolf GmbH · HF COAG. SUCTION TUBE OD 4.1MM WL 210MM knee bent, with monopolar HF connection, reusable · Class 2
Data updated Oct 16, 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 04055207014813), received between Feb 25, 2019 and Feb 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Fire1
- Smoking1
- Sparking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2019Break; Fire; Smoking; Sparking; Break; Fire; Smoking; Sparking
ON JANUARY 25, 2019,RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED MEDWATCH REPORT # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED: DURING THE PROCEDURE, SMOKE, A SPARK, AND A FLAME WERE OBSERVED COMING OFF THE BOVIE CORD WHERE IT CONNECTS TO THE HAND PIECE. AFTER THE FLAME, THE BOVIE CORD BROKE IN HALF. EARLIER IN THE CASE, THE STAFF AND SURGEON QUESTIONED THE PERFORMANCE OF THE BOVIE/SUCTION. THEY FELT THAT IT MAY NOT HAVE BEEN WORKING PROPERLY. AS SOON AS THE REGISTERED NURSE (RN) AT THE FIELD OBSERVED THE FLAME, THEY STATED TO EVERYONE IN THE ROOM "FIRE" AND THEN DOUSED THE BOVIE CORD WITH THE SALINE FROM THEIR BACK TABLE (AS PER PROTOCOL). THE CORD WAS REMOVED FOR THE FIELD AND SEQUESTERED. A NEW CORD WAS PLACED ON THE FIELD AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE BOVIE MACHINE, BOVIE PADS, AND THE DRAPES WERE ALL REMOVED AND SEQUESTERED. THERE WAS NO PATIENT INJURY REPORTED. THE SUSPECT MEDICAL DEVICE REPORTED IN THE MEDWATCH REPORT WAS THE SUCTION TUBE (PART NUMBER 8291.102 / LOT NUMBER 256S13). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MEDIASTINOSCOPY. WHAT PROBLEM DID THE USER HAVE? DEVICE FAILED. IS THIS A LABORATORY DEVICE OR LABORATORY
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8368473 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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