NA 8106033Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04055207000694), received between Dec 19, 2016 and May 8, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Sparking” (6 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2024Sparking; Sparking

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDWATCH REPORT, MW5153308 REGARDING AN ISSUE WITH A HF CONNECTION CABLE MONO L 3M, PART ID: 8106.033, BATCH # 442/771. THE MEDWATCH REPORT, MW5153308, STATES THAT THE, "BOVIE CORD SPARKED AND EXPLODED WHILE IN USE IN THE OPERATING ROOM DURING PATIENT SURGERY. PATIENT NOR STAFF WERE NOT HARMED, BUT A VERY HIG POTENTIAL FOR CATASTROPHIC OR FIRE." ACCORDING TO THE RECEIVED INFORMATION, WHILE PHYSICIAN WAS USING ENDO SHEARS CONNECTED TO MONOPOLAR CAUTERY CORD, SUDDENLY THE CONNECTION POINT OF THE CORD AND INSTRUMENT SPARKED AND BROKE. THE CORD WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM SURGICAL FIELD, ALONG WITH THE ENDO SHEARS. THERE WAS A 10 MINUTES DELAY TO RETRIEVE A NEW ENDO SHEARS AND A MONOPOLAR CORD. THE BACK-UP DEVICE WAS THEN PLUGGED INTO THE SAME UNIT WITH NO FURTHER COMPLICATIONS FOR THE REMAINDER OF THIS CASE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268491 ↗
• MalfunctionSep 27, 2023Sparking; Sparking

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING AN HF CONNECTION CABLE MONO L 3M, PART ID: 8106.033, BATCH # 747/675. ACCORDING TO THE RECEIVED INFORMATION, DURING A SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A RN CIRCULATOR WAS ATTEMPTING TO PLUG IN BOVIE CORD WHEN A SPARK FROM THE CORD OCCURRED. CORD INSPECTION REVEALED AN INSULATION FRAY WHERE THE SPARK HAPPENED. THERE WAS A REPORTED 5-10 MINUTES DELAY IN THE PROCEDURE. HOWEVER, CORD WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828134 ↗
• MalfunctionJun 1, 2022Fire; Fire

  IT WAS REPORTED TO RICHARD WOLF THAT "THE INSULATION LOOKS TO HAVE BEEN DAMAGED AND THE CORD WAS SEVERED AND CAUSED A FLAME TO BE EMITTED. THERE WAS NO PATIENT INJURY AS THIS DID HAPPEN [SIC] DURING A CASE" ADDITIONAL DETAILS: WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569538 ↗
• MalfunctionMay 31, 2022Fire; Sparking; Fire; Sparking

  IT WAS REPORTED TO RICHARD WOLF, MEDWATCH REPORT (B)(4) THAT THE "SURGICAL TEAM INSIDE CVOR ROOM 3. PATIENT ON CVOR TABLE, TIME OUT PERFORMED. EQUIPMENT PASSED TO CIRCULATING NURSE TO BE CONNECTED TO EQUIPMENT TOWER, SURGICAL PENCIL CORD, CAMERA CORD, LIGHT SOURCE CORD. SURGICAL PROCEDURE STARTED AT 11:52 AM. APPROXIMATELY 3 MIN AFTER PROCEDURE STARTED AT 11:55, SURGEON ATTEMPTED TO USE SURGICAL PENCIL PEDAL. THE SURGICAL PENCIL PEDAL CORD SPARKED TWICE AND A FLAME WAS NOTICED BY SURGICAL TEAM ON SURGICAL PENCIL CORD. SURGEON STOPPED THE USE OF THE DEVICE IMMEDIATELY AND A FULL ASSESSMENT OF THE PATIENT AND ROOM WAS PERFORMED. THERE WAS NO HARM TO PATIENT OR SURGICAL TEAM. SURGICAL PENCIL MACHINE, SURGICAL PENCIL PEDAL AND SURGICAL PENCIL CORD WERE EXCHANGED. SURGICAL PROCEDURE CONTINUED WITHOUT ANY OTHER ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552795 ↗
• MalfunctionJun 23, 2021Sparking; Detachment of Device or Device Component; Sparking; Detachment of Device or Device Component

  THE PURPOSE OF THIS REPORT IS ADD PATIENT INFORMATION RECEIVED FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051944 ↗
• MalfunctionJul 3, 2019Sparking; Sparking

  ON (B)(6) 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE CABLE SPARKED DURING THE PROCEDURE. NO PATIENT INJURY. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? NO. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757858 ↗
• MalfunctionFeb 25, 2019Break; Fire; Smoking; Sparking; Break; Fire; Smoking; Sparking

  ON JANUARY 25, 2019, (B)(4) RECEIVED MEDWATCH REPORT. 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 TEST? NO. IN ADDITION, TO THE MEDWATCH REPORT, (B)(4) TWO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368515 ↗
• MalfunctionDec 19, 2016Break; Fire; Break; Fire

  (B)(4) RECEIVED A MEDWATCH REPORT ((B)(4)) FROM THE FDA REGARDING AN INCIDENT WHERE A CABLE BROKE DURING USE, CAUGHT FIRE AND DAMAGED A GENERATOR ALSO IN USE. CABLE WAS UNPLUGGED AND FIRE CONTAINED WITH NO NEGATIVE RESULTS. BOTH THE CABLE AND THE GENERATOR WERE REMOVED AND REPLACED WITH BACKUP DEVICES. FACILITY FOUND DAMAGED CIRCUIT BOARD IN GENERATOR. NO INJURY TO PATIENT OR STAFF REPORTED. CABLE MANUFACTURER HAS BEEN NOTIFICATION OF EVENT, ALONG WITH CABLE ID AND SERIAL NUMBER OF DEVICE. CABLE HAS NOT BEEN RETURNED FOR INVESTIGATION AS OF 12/19/2106. (B)(4) HAS CONTACTED USER FACILITY FOR ADDITIONAL INFORMATION AND FOR THE RETURN OF CABLE, NO RESPONSE AS OF 12/19/2016 MANUFACTURER DATE: WEEK OF 11/30/2015. (B)(4) RECEIVED DATE: 12/15/2015. FACILITY PURCHASED DATE: 07/07/2016. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES THE DEVICE OR ANY ADDITIONAL INFORMATION, (B)(4) WILL PROVIDE MANUFACTURER WITH FOLLOW-UP INFORMATION/DEVICE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6186391 ↗