CONMED GOLDLINE 131319ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405056802), received between Mar 13, 2020 and Mar 13, 2020 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2020Sparking; Sparking

  ON BEHALF OF THEIR CUSTOMER, THE DISTRIBUTOR REPORTED ISSUES INVOLVING ITEM # 131319A , GOLDLINE, HAND CONTROLLED WITH ULTRACLEAN BLADE ELECTRODE, ROCKER SWITCH, LOT # 201901244, THAT WAS EXPERIENCED ON (B)(6) 2020. IT WAS REPORTED ONLY "HAND CONTROL PENCIL SPARKS". IT IS NOTED THAT THE ISSUE OCCURRED DURING SURGERY AND THERE WAS NO IMPACT OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS PLUGGED INTO THE CAUTERY MACHINE IN THE C-SECTION ROOM. SPARKS CAME FROM THE PENCIL TIP UPON IMMEDIATE USE, THERE WERE NO FLAMES. THE DEVICE WAS USED DURING A C-SECTION AND THE ISSUE OCCURRED IN A STERILE FIELD. THE STAFF CHANGED TO A DIFFERENT DISPOSABLE PENCIL TIP AND THE PROCEDURE WAS COMPLETED. NO OTHER INFORMATION WAS MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831390 ↗