NA 8108033Recalls & reported problems
Richard Wolf GmbH · HF CONNECTION CABLE BIPO L 3M plug Bovie/Valleylab/Erbe (Int.)/BOWA (Int.) R.Wolf HF surgery generator 400 kHz 2260001, 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 04055207000793), received between Feb 20, 2018 and Feb 20, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (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
- No Apparent Adverse Event1
- Sparking1
Patient problems
- No Known Impact Or Consequence 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 20, 2018Sparking; No Apparent Adverse Event; No Apparent Adverse Event
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY FACILITY THAT A NOISE WAS HEARD DURING THE PROCEDURE. HAND HELD SYSTEM WAS REMOVED FROM PATIENT, GENERATOR WAS ACTIVATED AND A SPARK WAS SEEN. A BACK UP DEVICE WAS READILY AVAILABLE FOR USE WITH MINIMAL DELAY TO PROCEDURE. PROCEDURE COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. HAND HELD SYSTEM CONSISTS OF THE FOLLOWING: KLEPPINGER; FORCEPS INSERT (INSERTED INTO KLEPPINGER); BIPOLAR CABLE (CONNECTS KLEPPINGER TO GENERATOR) (SUSPECT DEVICE). ADDITIONAL ITEMS PART OF SYSTEM: BIPOLAR GENERATOR ; POWER CORD, GENERATOR; FOOTSWITCH (CONNECTS TO GENERATOR). FACILITY HAS BEEN CONTACTED, VIA EMAIL, IN AN EFFORT TO GATHER ADDITIONAL/MISSING FOR THIS REPORT. NO RESPONSE RECEIVED AS OF 20FEB2018. FACILITY PURCHASED (B)(4) BIPOLAR CABLES (ID # 8108.033, LOT #348/665) FROM APRIL 28, 2014 THROUGH AUGUST 26, 2014. DEVICE APPROXIMATELY 4 YEARS OLD. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE LAST FIVE YEARS FOR THIS DEVICE (ID #8108.033). DEVICE HAS NOT BEEN RETURNED. IF RWMIC RECEIVES DEVICE, IT WILL BE SENT TO MANUFACTURER FOR INVESTIGATION. RWMIC CONSIDERS THIS REPORT CLOSED. IF RWMIC RECEIVES ADDITI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7283039 ↗
Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
- LigaSure LF1937Covidien LP · Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- Olympus WB91051WOLYMPUS Winter & Ibe GmbH · Electrosurgical, Cutting & Coagulation & Accessories1 death1,951 reports
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Covidien LP · Electrosurgical, cutting & coagulation & accessories948 reports
- VAPR 225028Depuy Mitek, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- LigaSure LF1923Covidien LP · Electrosurgical, cutting & coagulation & accessories855 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page