Valleylab CVPLP2000 (UDI 10884521194281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521194281), received between Jun 21, 2016 and Jul 21, 2025 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Inappropriate/Inadequate Shock/Stimulation; Electrical Shorting; Inappropriate/Inadequate Shock/Stimulation; Electrical Shorting

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DEVICE HAD CURRENT LEAKAGE. THE SURGEON FELT SHOCKS ON HIS FINGERS UPON ACTIVATING THE DEVICE. THE DEVICE MAY HAVE HAD A LOOSE WIRE. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: Electric Shock

  MAUDE report 22555666 ↗
• MalfunctionDec 29, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, THE DEVICE CAUTERY TIP WAS FIRING WITHOUT BEING PRESSED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419652 ↗
• MalfunctionSep 7, 2022Inappropriate/Inadequate Shock/Stimulation; Arcing; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD ARCING/SPARKING AND A BURN LIKE ENERGY WENT UP TO THE SURGEON'S ARM WHEN HE ACTIVATED THE BOVIE PENCIL ON THE DEBAKE GRASPER WITH TISSUE INSIDE THE JAW OF THE GRASPER. IT WAS REPORTED THAT THE SURGEON'S HAND WAS FINE.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 15375070 ↗
• MalfunctionAug 30, 2022Fire; Fire

  ACCORDING TO THE REPORTER, DURING LABOR AND DELIVERY, THE GENERATOR INADVERTENTLY JUMPED TO A HIGHER WATTAGE CAUSING THE PENCIL TO CATCH FIRE. A NEW GENERATOR AND PENCIL WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324427 ↗
• MalfunctionJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAP PROCEDURE, THE DOCTOR GOT A DEEP 2ND DEGREE BURN (2.5 CM X 2CM) IN THE FINGER DUE TO A SPARK FROM THE HANDPIECE (FREE AIR FROM ABDOMEN). IT WAS REPORTED THAT THE BURN WAS TREATED WITH NEOSPORIN AND BANDAID AND THE CURRENT STATUS OF THE DOCTOR IS STABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15112982 ↗
• MalfunctionJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LUMPECTOMY, WHEN THE DEVICE WAS USED ON THE BREAST, THE PATIENT HAD REDNESS THAT LOOKED LIKE A BURN ON THE SKIN AROUND THE INCISION. THEY BELIEVED THAT  IT WAS FROM THE PLASTIC SUCTION TUBE UNDER THE ELECTRODE MAYBE GETTING TOO HOT. THE PROCEDURE WAS COMPLETED AS NORMAL.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14777656 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD FIRE DURING THE CASE. THE PATIENT HAD SUPERFICIAL FACIAL BURN INJURIES ON HER FOREHEAD AND SCALP, AND EYE DAMAGE. THE PATIENT ALSO HAD BURN IN NECK AND UPPER BACK. THAT PATIENT HAD TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS. FIRE INCIDENT STOPPED THE PROCEDURE FROM OCCURRING. THE PATIENT HAD THESE BURNS WHILE HAVING REMOVAL OF LESION OFF HER FOREHEAD. SURGICAL INTERVENTION NEEDED WAS TREATMENT OF BURNS, PLASTIC AND OPHTHALMOLOGY. TIVA WITH OXYGEN MASK WAS BEING USED AND CHLORAPREP WAS USED AS INDICATED. THE PATIENT HAD EXTENDED HOSPITALIZATION FOR 2 DAYS.

  Patient problems: Burn(s); Eye Injury

  MAUDE report 14580104 ↗
• MalfunctionMar 23, 2022Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, DURING RIGHT TOTAL HIP - DIRECT ANTERIOR PROCEDURE, THE TIP CAUGHT FIRE AND MELTED DURING USE. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE REPORTED. THERE WAS NO REPORTED BLOOD LOSS. NOTHING FELL INTO PATIENT'S CAVITY. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866833 ↗
• MalfunctionMar 11, 2022Peeled/Delaminated; No Apparent Adverse Event; Peeled/Delaminated; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSULATED COATED TIP OF THE SMOKE EVACUATOR PENCIL WAS COMING OFF TO CLEAR THE ESCHAR BUILD UP BY USING ONE'S FINGER ON THE BACK TABLE THAT PULLS AT THE CLEAR PLASTIC. IT WAS ALSO REPORTED THAT THE BOTTOM SECTION (BLUE INSULATION) WAS COMING OFF AFTER THE CASE AS THE TECHNICIAN REMOVE THE TIP FOR DISPOSAL USING AN INSTRUMENT. THE INSULATION PEELED ONLY AND NOTHING FELL INTO PATIENT'S CAVITY. NO X-RAY OR ANY ADDITIONAL MEDICAL PROCEDURE WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13733951 ↗
• MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SMOKE EVACUATION PENCIL COVERED TIP SEPARATED, SO THE COVERED TIP BECAME LOOSE ON THE METAL BLADE AND A POTENTIAL RETAINED OBJECT. ALL PIECE OR PART THAT FELL INTO PATIENT'S CAVITY WAS FULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577194 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PIECE OF SUCTION SMOKE TUBE BROKE OFF. NOTHING FELL INTO PATIENTS CAVITY. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089774 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A BOVIE SUCTION PIECE BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085384 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE'S SUCTION PIECE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 12064327 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE'S SUCTION PIECE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 12064297 ↗
• MalfunctionJan 27, 2021Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE SURGEON HAD HIS LEFT HAND BEHIND THE ABDOMINAL WALL WHILE USING THE PENCIL DEVICE IN HIS RIGHT HAND ON 30-COAG POWER SETTINGS TO OPEN THE FASCIAL LAYER. THE SURGEON FELT A SHOCK ON HIS LEFT INDEX FINGER WHILE ACTIVATING THE DEVICE, WHICH HE DESCRIBED AS TRAVELLING UP HIS ARM AND DOWN HIS LEG. HE SUFFERED A SMALL BURN ON HIS FINGER AND WAS WELL. THE DEVICE WAS RULED OUT OF THE INCIDENT, AND SINCE THIS BATCH OF DIATHERMY PENCILS HAVE BEEN PUT BACK INTO USE, THERE WAS NO NEED TO FOLLOW UP THE INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 11235485 ↗
• MalfunctionJan 8, 2021Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROUTINE BLEPHAROPLASTY, A BURN OCCURRED ON THE SURGEON'S HAND. A SPARK FLEW OFF THE ELECTRODE IN THIS PENCIL ONTO THE HAND. ANOTHER SINGLE USE SMOKE PENCIL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138952 ↗
• MalfunctionDec 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BREAST PROCEDURE, THE RETRACTABLE SMOKE TUBE ON PENCIL BROKE. THE RETRACTABLE CANNULA SHATTERED DURING THE CASE. IT FELL INTO THE PATIENT'S CAVITY BUT PIECES WERE RETRIEVED AND RETURNED. INTERVENTIONS WERE MADE TO VERIFY THAT THERE WERE NO PARTS LEFT IN THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067467 ↗
• MalfunctionDec 7, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING LYMPH NODE BIOPSY, THE DEVICE SPARKS AND FLAME WHEN SURGICAL PROVIDER WAS USING BOVIE TIP TO FORCEPS. FLAME AND FORCEP WAS AWAY FROM THE PATIENT. THE OPERATING ROOM (OR) TEAM WAS NOTIFIED. NEW DEVICE TIP WAS USED WITHOUT FURTHER INCIDENT. ALL ITEMS GIVEN TO BIOMED TO EVALUATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959296 ↗
• MalfunctionNov 24, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ABOUT 1 HOUR INTO CASE, THE DEVICE'S TIP WAS SUDDENLY CAUGHT ON FIRE. FIRE DID NOT TOUCH PATIENT AND WAS PROMPTLY EXTINGUISHED COMPLETELY.

  Patient problems: Insufficient Information

  MAUDE report 10894232 ↗
• MalfunctionNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PIECE OF PLASTIC BROKE OFF OF PART OF THE DEVICE BUT NOT INTO PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10850482 ↗
• MalfunctionNov 6, 2020Fire; Sparking

  BOVIE SPARKS AND FLAME NOTED WHEN SURGICAL PROVIDER WAS USING BOVIE TIP TO FORCEP. FLAME WAS NOT NEAR THE PATIENT, WAS NOTED ON FORCEP AND WAS AWAY FROM THE PATIENT. THE OR TEAM WAS NOTIFIED. NEW BOVIE TIP WAS USED WITHOUT FURTHER INCIDENT. ALL ITEMS GIVEN TO BIOMED TO EVALUATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10800798 ↗
• MalfunctionOct 26, 2020Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S CAUTERY TIP CAUGHT ON FIRE SUDDENLY ABOUT AN HOUR INTO CASE. THE FIRE DID NOT TOUCH PATIENT AND WAS PROMPTLY EXTINGUISHED COMPLETELY.

  Patient problems: No Information

  MAUDE report 10734846 ↗
• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON USED A GUARDED TIP WITH CVPLP AND THE SUCTION TUBE BROKE OFF AND FELL INTO THE SURGICAL FIELD. A PIECE OR PART FELL INTO PATIENT CAVITY BUT IT WAS FULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565519 ↗
• MalfunctionAug 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, THE CLEAR PLASTIC SMOKE TUBE NEAR THE ACTIVE ELECTRODE EXPLODED. PIECES OF CLEAR PLASTIC HAD BROKEN OFF . THE SURGEON WAS ACTIVELY USING THE SMOKE PENCIL WHEN IT OCCURRED. THEY DID KEPT THE PENCIL AND THERE WAS AN OBVIOUS BROKEN PLASTIC AT THE TIP OF THE SMOKE EVACUATION TUBE NEAR THE ELECTRODE. IT WAS CONFIRMED THAT NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS DONE USING THE SAME CAUTERY AND DID NOT NEED ANOTHER CAUTERY PENCIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10463038 ↗
• MalfunctionMay 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC PERFORATORS (DIEP) FLAP BREAST RECONSTRUCTION, THE DEVICE'S CAPTURE TUBE BROKE INTO HALF AND FELL APART. A PIECE OR PART FELL INTO THE PATIENT'S CAVITY. THE PIECE WAS FULLY RETRIEVED, THE PATIENT DID NOT UNDERGO ANY FURTHER MEDICAL OR SURGICAL INTERVENTIONS DUE TO THE DISENGAGED PIECE/PART, AND AN X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE PIECE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10084225 ↗