GoldVac 60-7520-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30653405056342), received between Nov 16, 2017 and Nov 1, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-7520-005, ROCKER SWITCH ELECTROSURGICAL SMOKE EVACUATION HANDPIECE, WAS BEING USED DURING A LAPAROTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿I RECEIVED AN EMAIL FORM THE HOSPITAL STATING THAT THE ROCKER SWITCH FELL OFF INTO THE ABDOMEN AND WAS RETRIEVED BY THE SURGEON." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY REPORTED. 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 20585743 ↗
• MalfunctionJul 24, 2018Material Separation; Material Separation

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING PRE-OP TESTING FOR AN ORTHOPEDIC PROCEDURE, A PIECE OF THE 60-7520-005 GOLDVAC SMOKE PENCIL FELL OUT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH 5 MINUTE DELAY. NO PATIENT CONTACT OR INJURY WAS REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715732 ↗
• MalfunctionMay 4, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE 60-7520-005, GOLDVAC RS SMOKE PEN, HAD A PIECE OF PLASTIC FALL FROM THE DEVICE AND INTO THE SURGICAL SITE OF THE PATIENT DURING A SIGMOID COLON RESECTION PROCEDURE ON (B)(6) 2018. THE ASSISTING SURGEON NOTICED THE FRAGMENT AND REMOVED IT FROM THE PATIENT BY HAND. THERE WAS NO REPORT OF HARM TO THE PATIENT AND THE CURRENT STATUS OF THE PATIENT IS REPORTED AS STABLE. THERE WAS NO EXTENDED HOSPITAL STAY, NO REPORT OF DELAY OF PROCEDURE AND THE SURGERY COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486251 ↗
• MalfunctionNov 16, 2017Failure to Auto Stop; Failure to Auto Stop

  A CONMED REPRESENTATIVE REPORTED ON BEHALF OF A USER FACILITY THAT DURING SURGERY THE 60-7520-005 GOLDVAV SMOKE PEN ACTIVATED WITHOUT THE SWITCH BEING PRESSED. THE SMOKE EVACUATOR WAS ALSO REPORTED TO OPERATE CONTINUOUSLY. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE REGARDING PATIENT STATUS OR THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED BASED ON A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038803 ↗