Megadyne 0039HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10614559100868), received between Aug 29, 2019 and Sep 16, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE THREW OFF THE ELECTRIC SPARKS. NEXT (B)(6) MEDICALNEXT¿S ELECTRIC KNIFE WAS USED WITH THE DEVICE. THE SETTING VOLTAGE WAS 45·45, 40·40 WHEN IT SPARKED. COMPETITIVE GENERATOR WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482385 ↗
• MalfunctionApr 15, 2021Self-Activation or Keying; Human-Device Interface Problem; Self-Activation or Keying; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED RADICAL CYSTECTOMY AFTER THE LAPAROSCOPIC NEPHRECTOMY WAS COMPLETED, THE DEVICE FUNCTIONED PROPERLY AT THE EARLY PART OF THE PROCEDURE. 0012M,0039H AND VIO300D (ERBE) WAS USED TOGETHER. THEN UNTIL USING THE DEVICE AGAIN, THEY WERE PLACED TOGETHER IN A VINYL BAG WITH THE OTHER ENERGY DEVICE AND SUCTION/IRRIGATION DEVICE. LIQUID AND BLOOD LEAKING FROM THE SUCTION/IRRIGATION DEVICE HAD ACCUMULATED IN A VINYL BAG. THE DEVICES WERE SOAKED IN LIQUID. THEN THE ACTIVATION SOUND WAS HEARD FROM THE VINYL BAG WHEN THE SURGEON TRIED TO USE THE DEVICE AT THE LATTER PART OF THE OPERATION. AT THIS TIME, THE FOOTSWITCH OR THE HAND SWITCH WAS NOT PRESSED. THE SURGEON THOUGHT SOMETHING WAS WRONG, AND THE MEGADYNE CABLE WAS PLUGGED IN AND OUT FROM THE VIO 300D. THE POWER STOPPED FLOWING WHEN IT¿S PULLED OUT, BUT WHEN IT¿S PLUGGED IN, THE POWER FLOWED ON ITS OWN. WHILE THE SURGEON WAS PLUGGING IN AND OUT THE CABLE, THE TIP OF THE MEGADYNE WAS TOUCHING THE PATIENT¿S ABDOMEN, AND THE PATIENT GOT A BURN ABOUT 8CM LONG. THE DOCTOR INFORMED THE PATIENT'S FAMILY ABOUT THE BURN AND GAVE SOME OINTMENT TO TAKE CARE OF IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673892 ↗
• MalfunctionNov 1, 2019Contamination /Decontamination Problem

  IT WAS REPORTED BY THE SALES REP THAT, THERE WAS A FOREIGN MATTER IN EACH PACKAGE OF 0037H AND 0039H. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE 0037H AND ONE 0039H WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. AFFILIATE REFERENCE NUMBER: (B)(4). POTENTIAL VOC: PACKAGING FOREIGN MATTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266289 ↗
• MalfunctionOct 22, 2019Flare or Flash

  IT WAS REPORTED THAT DURING A HERNIA PROCEDURE THERE WAS A FLASH AT THE SURGICAL SITE. NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221691 ↗
• MalfunctionAug 29, 2019Flare or Flash

  IT WAS REPORTED THAT DURING A MASS EXCISION THERE WAS A FLASH AS THE SURGICAL SITE FROM EITHER THE PENCIL OR THE TIP. IT IS UNKNOWN HOW THEY FINISHED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946953 ↗