ABC® Bend-A-Beam® 134006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10653405002758), received between Oct 3, 2017 and Jan 8, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fire” (3 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 18, 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.

• MalfunctionJan 8, 2019Break; Break

  THE CUSTOMER REPORTED THAT DURING SURGERY ON (B)(6) 2018 THE TIP OF THE ARGON BEAM HANDPIECE WARPED, AND PART OF THE TIP BROKE OFF. THE TIP WAS VERY SMALL AND COULD HAVE EASILY FELL INTO THE PATIENT. WHEN THE TIP BROKE A SHARP POINTY NEEDLE WAS EXPOSED. THERE WAS NO REPORTED INJURY OR DELAY OF SURGERY. FURTHER ATTEMPTS TO GATHER INFORMATION WERE MADE BUT NOTHING ADDITIONAL OTHER THAN A DEVICE NUMBER AND LOT NUMBER COULD BE PROVIDED. 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 8227292 ↗
• MalfunctionNov 13, 2018Fire; Flare or Flash; Fire; Flare or Flash

  PER THE ATTENDING SURGEON THE 134006 ARGON BEAM HANDPIECE BEGAN SHOOTING FLAMES AND A NEW HANDPIECE NEEDED TO BE USED. THIS REPORT WAS RECEIVED OFF THE MAUDE DATABASE. THERE IS NO OTHER ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON "REOCCURENCE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065545 ↗
• MalfunctionOct 30, 2018Sparking; Sparking

  THE CUSTOMER REPORTED AN ISSUE WITH THE 134006, 6" BEND-A-BEAM MALABLE ABC (ARGON BEAM COAGULATOR) HP (HANDPIECE) DEVICE. IT WAS REPORTED THAT THE SURGEON WAS HOLDING HAND PIECE ABOVE ABDOMEN WHEN A SPARK OCCURRED AT DISTAL END THAN A FLAME. THE PRODUCT WAS SUBMERGED IN WATER AND UNIT WAS UNPLUGGED. THERE WAS NO REPORTED INJURY OR IMPACT TO THE PATIENT OR USER. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE ISSUE OCCURRED AT THE END OF THE GYNONC DEBULKING PART OF THE PROCEDURE. THE DEVICE WAS IN THE SURGEON'S HAND ABOVE AND PERPENDICULAR TO THE PATIENT WHEN THE SPARK OCCURRED AND IMMEDIATELY THE FLAME WAS NOTED. THE HEAT MELTED THE PLASTIC COVERING ON THE TIP. THE HANDPIECE WAS IMMEDIATELY SUBMERGED INTO WATER. IT IS INDICATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. 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 8018791 ↗
• MalfunctionSep 27, 2018Fire

  PER THE ATTENDING SURGEON, THE HANDPIECE BEGAN "SHOOTING FLAMES" AND A NEW HANDPIECE NEEDED TO BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7913683 ↗
• MalfunctionOct 3, 2017Fire; Fire

  THE USER FACILITY REPORTED THAT DURING AN EXTENSIVE GYNECOLOGY PROCEDURE, A BEND-A-BEAM THAT WAS IN USE CAUGHT FIRE AT THE DISTAL TIP OF THE HANDPIECE. THIS EVENT OCCURRED NEAR THE END OF THE PROCEDURE, AND PRIOR TO THIS INCIDENT THERE WERE NO ISSUES WITH THE DEVICE. A NEW HANDPIECE WAS USED TO FINISH THE PROCEDURE WITH NO REPORTED PROCEDURAL DELAYS. NO PATIENT INJURY REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6911594 ↗