GoldVac 60-7510-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30653405056335), received between Mar 15, 2016 and Dec 18, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2024Firing Problem; Firing Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005, PUSH BUTTON ELECTROSURGICAL SMOKE EVACUATION HANDPIECE WAS BEING USED ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿THE CUT FUNCTION WAS ENGAGED FOR THE ENTIRE TIME IT WAS PLUGGED IN AND EVEN THOUGH THE SURGEON WAS PRESSING THE COAG BUTTON, IT WAS CUTTING. THIS CAUSED EXCESS BLEEDING AND SKIN LACERATIONS BEFORE IT WAS DISCOVERED AND SWITCHED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND A TWO-MINUTE DELAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF EXCESS BLEEDING AND SKIN LACERATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 20964577 ↗
• MalfunctionJul 30, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS), WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿PRIOR TO THE START OF SURGERY, CAUTERY PENCIL WAS PLUGGED IN AND RESTING ON THE PATIENTS LAP. WITHOUT ANY MEMBER OF THE SURGICAL TEAM ACTIVATING OR TOUCHING IT, THE CAUTERY TURNED ON AN BURNT A SMALL HOLE THROUGH THE DRAPE.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860603 ↗
• MalfunctionJul 29, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS) WAS BEING USED ON 4JUL24 AND ¿THE CAUTERY PEN SUDDENLY ACTIVATED DURING SURGERY WITHOUT ANYONE PRESSING ANY BUTTONS. IT DID NOT STOP. THE TEAM SWITCHED OUT THE CAUTERY MACHINE AND THE ISSUE PERSISTED. THEY OPENED A NEW DEVICE WITHOUT FURTHER PROBLEMS.¿ THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851173 ↗
• InjuryMar 4, 2024Insufficient Device Problem Information; Intermittent Energy Output; Insufficient Device Problem Information; Intermittent Energy Output

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS), WAS BEING USED DURING A BREAST AUGMENTATION WITH IMPLANTS PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿FIRE ERUPTED UNDER A ROUTINE BREAST AUGMENTATION PROCEDURE WITH BREAST IMPLANTS.¿ THE FIRE WAS EXTINGUISHED, AND THE PATIENT SUFFERED 2ND AND 3RD DEGREE BURNS TO THE RIGHT THORAX AND RIGHT UPPER EXTREMITY, APPROXIMATE 5% TBSA. SECONDARY PROCEDURE FOR SKIN GRAFT NEXT DAY. DURING THE PROCEDURE THE USER NOTICED INTERMITTENT PROBLEMS WITH THE COAG BUTTON ON THE DIATHERMY PEN. IT HAPPENED 3 - 4 TIMES DURING THE OPERATION THAT THE COAG BUTTON DID NOT RESPOND THE FIRST TIME THE BUTTON WAS PRESSED. WHEN THE BUTTON WAS PRESSED AGAIN, IT SEEMED TO FUNCTION AS NORMAL. A WHILE LATER THE SAME PROBLEM REPEATED ITSELF. WHEN THIS PROBLEM OCCURRED AGAIN, THE USER CHECKED THAT THE DIATHERMY PAD WAS PROPERLY ATTACHED TO THE PATIENT AND ALSO THAT THERE WERE NO ERROR MESSAGES FROM THE DIATHERMY APPARATUS. AS IT SEEMED TO FUNCTION CORRECTLY WHEN THE USER PRESSED THE COAG BUTTON TWICE, THE USER DID NOT SEE A REASON TO CHANGE THE SET. THERE HAD PASSED APPROXIMATELY 5 MINUTES FROM WHEN THE USER HAD

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 18825245 ↗
• InjuryJul 14, 2023Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL PUSHBUTTON WAS BEING USED ON (B)(6) 2023 DURING A C-SECTION AND MYOMECTOMY PROCEDURE AND THE ¿PATIENT BURNED WITH CAUTERY GOING OFF WITHOUT ENGAGING THE BUTTON¿. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE DELAY TO "OPEN FEW CAUTERIES". FURTHER ASSESSMENT FOUND THE DEVICE WAS NOT BEING USED AT THE TIME OF THE BURN, "IT WASN`T USED BUT LEFT ON PATIENT ABDOMEN WHEN ACTIVATED.". A TOTAL OF THREE DEVICES (60-7510-005) WITH 2 LOT NUMBERS (202302234 AND 202303035) WERE USED IN THIS PROCEDURE AND IT IS NOT KNOWN WHICH LOT WAS INVOLVED IN THE BURN. "STAFF OPENED THREE CAUTERIES AND INCIDENT HAPPENED WITH ONE OF THESE LOTS AS WE CAN NOT IDENTIFY.". THE DEGREE OF THE BURN THE PATIENT RECEIVED IS NOT KNOWN. IT IS NOT KNOWN IF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE ELECTRICAL SURGICAL UNIT USED WAS A VALLEYLAB FT10 AND WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 17325830 ↗
• InjuryJul 14, 2023Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL PUSHBUTTON WAS BEING USED ON (B)(6) 23 DURING A C-SECTION AND MYOMECTOMY PROCEDURE AND THE ¿PATIENT BURNED WITH CAUTERY GOING OFF WITHOUT ENGAGING THE BUTTON¿. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE DELAY TO "OPEN FEW CAUTERIES". FURTHER ASSESSMENT FOUND THE DEVICE WAS NOT BEING USED AT THE TIME OF THE BURN, "IT WASN`T USED BUT LEFT ON PATIENT ABDOMEN WHEN ACTIVATED.". A TOTAL OF THREE DEVICES (60-7510-005) WITH 2 LOT NUMBERS (202302234 AND 202303035) WERE USED IN THIS PROCEDURE AND IT IS NOT KNOWN WHICH LOT WAS INVOLVED IN THE BURN. "STAFF OPENED THREE CAUTERIES AND INCIDENT HAPPENED WITH ONE OF THESE LOTS AS WE CAN NOT IDENTIFY.". THE DEGREE OF THE BURN THE PATIENT RECEIVED IS NOT KNOWN. IT IS NOT KNOWN IF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE ELECTRICAL SURGICAL UNIT USED WAS A VALLEYLAB FT10 AND WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 17325828 ↗
• InjuryJul 13, 2023Self-Activation or Keying; Self-Activation or Keying

  UPDATE: PER REPORTER: "UNFORTUNATELY I HAVE BAD NEWS. SEVERAL STAFF OF THE DEPARTMENT HAVE BEEN ASKED FOR DETAILS TO HELP RESPOND TO YOUR QUESTIONS AND NOBODY HAS ANY INFORMATION FOR US. I AM UNABLE TO GET YOU ANY FURTHER DETAILS TO THE PARTICULAR INCIDENT.". THE CUSTOMER REPORTED THAT THE 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL PUSHBUTTON WAS BEING USED ON (B)(6) 2023 AND THE ¿CAUTERY WOULD NOT TURN OFF. NO BUTTONS PUSHED AND STILL ON BURN MODE. BURNED SKIN + DRAPE BEFORE WE NOTICED SPARKING.". FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, NO NEW INFORMATION HAS BEEN OBTAINED. THE REPORTER RESPONDED THE SURGEON IS OUT OF TOWN UNTIL AUGUST AND WILL RESPOND WITH ANSWERS TO ASSESSMENT QUESTIONS AT THAT TIME. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 17320853 ↗
• MalfunctionApr 26, 2023Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005 GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS) WAS BEING USED ON 4APR23 DURING A GENERAL SURGERY PROCEDURE AND ¿THIS IS A SAFETY CONCERN AS CAUTERY MALFUNCTIONED MID CASE. THE CAUTERY TURNED ON WITHOUT ACTIVATING ANY BUTTONS CUT OR COAG /FOOT PEDAL. PATIENT WAS BURNED ON THE ABDOMEN.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. AFTER FURTHER ASSESSMENT IT WAS FOUND THE PATIENT RECEIVED A 1ST DEGREE BURN AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED FOR THE BURN. ALSO, IT WAS FOUND THAT "THE DEVICE WAS ON PATIENT, NOT IN USE WHEN IT GOT ACTIVATED.". THE "PATIENT IS DOING OK". IT WAS REPORTED THAT NO PROLONGED HOSPITALIZATION WAS REQUIRED "FOR THIS REASON". THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16814161 ↗
• MalfunctionMar 25, 2022Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-7510-005, GOLDVAC INTEGRATED SMOKE PENCIL, PUSHBUTTON (10/CS), WAS USED DURING AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿WHILE FINISHING SURGERY IN OR-1 THE CAUTERY TURNED ON BY ITSELF ONTO CUT. IT WOULD NOT TURN OFF TILL THE MACHINE WAS TURNED OFF.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13899878 ↗
• MalfunctionDec 11, 2018Misfire; Firing Problem; Misfire; Firing Problem

  THE CUSTOMER REPORTED THAT THE (B)(4), GOLDVAC PB SMOKE PENCIL, WHILE STARTING THE CIRCUMCISION, SURGICAL PROCEDURE ON (B)(6) 2018 THE ELECTROSURGICAL SMOKE EVACUATION HANDPIECE FIRED WITHOUT SURGEON TOUCHING BUTTON. THE SURGEON WAS ABOUT TO START USING HANDPIECE, AIMED IN THE DIRECTION OF THE SURGICAL LOCATION. DEVICE BUTTON WAS NOT PRESSED YET ACCORDING TO SURGEON THE DEVICE ENGAGED IN CUT MODE. SURGEON DOUBLED CHECKED HIS HAND PLACEMENT. DEVICE DID GO OFF ON ITS OWN AGAIN. THE CUT ON THE PENIS WAS WHERE THE SURGEON WAS GOING TO INITIATE THE SURGICAL INCISION, SO ACCORDING TO THE DOCTOR THERE WERE NO ISSUES AN NO HARM TO THE PATIENT. THE YELLOW BUTTON ON HANDPIECE WAS DIFFICULT TO PRESS AND APPEARED STUCK AND DIFFICULT TO RELEASE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152896 ↗
• MalfunctionAug 31, 2017Self-Activation or Keying; Self-Activation or Keying

  A C-SECTION WAS GOING TO BE PERFORMED WITH THE ASSISTANCE OF A GOLDVAC INTEGRATED SMOKE PENCIL. THE GOLDVAC CAUTERY PENCIL WAS PLACED IN THE BAG OF THE C-SECTION DRAPE, WHERE IT TURNED ON. THE SURGEON PICKED IT UP AND IT DID NOT STOP; IT KEPT WORKING WITHOUT THE BUTTONS BEING PRESSED. TO TURN OFF THE GOLVAC PENCIL, IT HAD TO BE UNPLUGGED FROM THE MACHINE. THE PATIENT SUFFERED A BURN ON HER THIGH. THIS EVENT OCCURRED DURING PRE-OP TESTING, NOT DURING SURGERY. FOUR ATTEMPTS TO GATHER MORE INFORMATION FROM THE USER FACILITY AND REPORTER WERE MADE. THE DEGREE OF THE BURN, PROCEDURE COMPLETION/DELAYS, OR ADDITIONAL TREATMENTS ARE UNKNOWN, TO DATE. THIS REPORT IS MADE ON THE BASIS OF A REPORTED MALFUNCTION, WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: Burn(s)

  MAUDE report 6836362 ↗
• MalfunctionNov 18, 2016Self-Activation or Keying; Self-Activation or Keying

  AS REPORTED BY THE USER FACILITY, "ON (B)(6) 2016, A GOLDVAC PENCIL, REF 60-7510-005, ACTIVATED PRIOR TO USE ON PATIENT WITHOUT DEPRESSING THE PUSH BUTTON TO ACTIVATE THE PENCIL." THERE WAS NO HARM TO THE OPERATING ROOM STAFF AND THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS ABLE TO HAVE THE RIGHT VATS LUNG BIOPSY PROCEDURE USING ANOTHER LIKE DEVICE THAT WAS ON HAND WITH ONLY A 5 MINUTE DELAY. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6114613 ↗
• Mar 16, 2016Fire

  THE CUSTOMER REPORTED THAT DURING USE OF THE GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL IN A PEDIATRIC TONSILLECTOMY PROCEDURE, AND AS THE GOLDVAC PENCIL WAS BEING UTILIZED TO CAUTERIZE THE TONSIL BEDS, THE USER NOTICED THERE WAS A FLASH AND A FLAME AT THE TIP OF THE DEVICE. FOLLOW-UP WITH THE USER FACILITY INDICATED THAT THERE WAS EXTENSIVE CHARRING ON THE MEDADYNE ELECTRODE TIP THAT WAS BEING UTILIZED WITH THE GOLDVAC PENCIL. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY REVEALED THAT THIS INCIDENT OCCURRED AT THE END OF THE PROCEDURE AND THAT THE FIRE WAS BRIEF AND WENT OUT BY ITSELF. THERE WAS NO INJURY TO PATIENT OR END-USER OF THE DEVICE WITH THIS REPORTED INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5505474 ↗
• Mar 15, 2016Fire; Hole In Material; Smoking

  THE CUSTOMER REPORTED THAT DURING A MODIFIED RADICAL MASTECTOMY AND UTILIZATION OF A GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL, A PENCIL BURN WAS INCURRED ON THE SURGEON'S FINGER. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE SURGEON OBTAINED A MINOR BURN TO HIS FINGER THAT WAS UNTREATED; YET, REQUIRED A CHANGE TO HIS GLOVE FOR THE GLOVE SUSTAINED A HOLE IN IT. AS REPORTED BY THE SURGICAL STAFF, THE BURN OCCURRED WHILE THE PHYSICIAN HAD THE GOLDVAC PENCIL IN HIS RIGHT HAND AND HE WAS DISSECTING TISSUE WHICH WAS HELD IN HIS LEFT HAND. THE REPORT FURTHER STATED, WHILE THE SURGEON WAS CHANGING HIS GLOVE, HIS SURGICAL ASSISTANT NOTICED THE FLAME ON THE SPONGE ON THE PATIENT'S OPEN WOUND. THE FLAME WAS IMMEDIATELY EXTINGUISHED WITH A WET TOWEL. THERE WAS NO PATIENT INJURY OCCURRING FROM THIS REPORTED INCIDENT. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT OR SURGICAL DELAY REPORTED.

  Patient problems: Burn(s)

  MAUDE report 5501163 ↗