EndoBeam™ Holmium Laser Fiber SU0200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741122194), received between May 1, 2017 and Aug 7, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Break; Material Fragmentation; Noise, Audible; Material Fragmentation

  IT WAS REPORTED THAT THE USER HEARD A SNAPPING SOUND AND THE DEVICE WAS BROKEN IN A SHORT TIME AFTER THE LASER IRRADIATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10382165 ↗
• MalfunctionJul 17, 2020Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LASER FIBERS HAD ALREADY BEEN FOUND BROKEN WHILE TAKING IT OUT FROM THE SHAFT SECTION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10290084 ↗
• MalfunctionNov 13, 2019Failure to Power Up; Failure to Power Up; Defective Device

  IT WAS REPORTED THAT THE ENDOBEAM HOLMIUM LASER FIBER WAS UNABLE TO IRRADIATE THE TARGET AREA ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9317847 ↗
• MalfunctionFeb 20, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BENT UPON OPENING THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8355277 ↗
• MalfunctionFeb 4, 2019Break

  IT WAS REPORTED THAT THE FIBER WAS BROKEN DURING USE. THE DEVICE WAS STILL USED AND THE SURGERY WAS ABLE TO BE COMPLETED. NO ADDITIONAL TREATMENT WAS REQUIRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8301488 ↗
• MalfunctionOct 10, 2018Break

  IT WAS REPORTED THAT THE LASER FIBER BROKE AND THE NURSE REPORTEDLY GOT BURNED ON THE CHIN AS A RESULT OF THE BREAK. THIS ALLEGEDLY RESULTED IN RED SPOTS ON THE NURSE'S SKIN. NO MEDICAL INTERVENTION WAS REQUIRED. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 26SEP2018, THE FIBER BROKE RIGHT AFTER ATTACHMENT TO THE LASER.

  Patient problems: Burn(s); Burn, Thermal; Skin Discoloration

  MAUDE report 7953716 ↗
• MalfunctionFeb 7, 2018Self-Activation or Keying; Device Operates Differently Than Expected

  IT WAS REPORTED THAT IMPROPER LASING OCCURRED ON THE PRODUCT; THE LASER FROM THE FIBER COULD NOT BE STOPPED BEFORE USAGE.

  Patient problems: No Information

  MAUDE report 7247304 ↗
• MalfunctionJan 29, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE LASER FIBER BROKE IN THE PATIENT'S LEFT KIDNEY DURING A LITHOTRIPSY. THE COMPLAINANT REPORTED THAT THE LASER SETTING WAS 0.4 JOULES AND RATE OF 50. THE TIP WAS RETRIEVED USING A STONE BASKET DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7225670 ↗
• MalfunctionDec 19, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE USER FOUND THAT THE DEVICE DID NOT LIGHT WHEN THEY TRIED TO USE IT, AND ANOTHER ONE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128385 ↗
• MalfunctionJul 25, 2017Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE WAS BROKEN IN THE MIDDLE.

  Patient problems: No Patient Involvement

  MAUDE report 6742778 ↗
• MalfunctionMay 23, 2017Break

  IT WAS REPORTED THAT AN ADDITIONAL USED LASER FIBER SAMPLE WAS RECEIVED WITH A SAMPLE FOR A SEPARATE COMPLAINT. THE LASER FIBER WAS RECEIVED WITH A BROKEN TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585604 ↗
• MalfunctionMay 23, 2017Break

  IT WAS REPORTED THAT AN ADDITIONAL USED LASER FIBER SAMPLE WAS RECEIVED WITH A SAMPLE FOR A SEPARATE COMPLAINT. THE LASER FIBER WAS RECEIVED WITH A BROKEN TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585541 ↗
• MalfunctionMay 23, 2017Break; Material Separation

  IT WAS REPORTED THAT AN ADDITIONAL USED LASER FIBER SAMPLE WAS RECEIVED WITH A SAMPLE FOR A SEPARATE COMPLAINT. THE LASER FIBER WAS RECEIVED WITH A BROKEN TIP.

  Patient problems: No Code Available

  MAUDE report 6585498 ↗
• MalfunctionMay 23, 2017Break

  IT WAS REPORTED THAT AN ADDITIONAL USED LASER FIBER SAMPLE WAS RECEIVED WITH A SAMPLE FOR A SEPARATE COMPLAINT. THE LASER FIBER WAS RECEIVED WITH A BROKEN TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585492 ↗
• MalfunctionMay 1, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT THE FIBER WAS BROKE WHEN THE USER TRIED TO REMOVE IT FROM THE ENDOSCOPE AFTER TREATMENT FOR RENAL STONES. THERE WAS NOT ANY PATIENT OR USER INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534158 ↗