VS3-IR 161-0001 (UDI 18130400103625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18130400103625), received between Aug 21, 2022 and Mar 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 17, 2022Class IIOpen, Classified

   Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.

   Z-0282-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 29, 2023Thermal Decomposition of Device; Fire; Arcing; Thermal Decomposition of Device; Fire; Arcing

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE LASER COULD NOT BE USED DURING SURGERY. AT THE END A DETAILED REVIEW WAS MADE AND SPARK OF FIRE CAME OUT OF THE BEAM COMBINER'S CABLE. THE SYSTEM AGE IS 1 YEAR. THE UNIT EQUIPMENT WAS TURNED OFF. THERE WAS NO OPERATING ROOM FIRE. A VIDEO AND PHOTO WERE ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638113 ↗
• MalfunctionSep 14, 2022Smoking; Smoking

  ACCORDING TO THE REPORTER, DURING AN EVALUATION WITH A DEMO UNIT, THE BEAM COMBINER WAS SMOKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415513 ↗
• MalfunctionAug 22, 2022Thermal Decomposition of Device; Device Damaged Prior to Receipt by User; Material Integrity Problem; Thermal Decomposition of Device; Device Damaged Prior to Receipt by User; Material Integrity Problem

  PRIOR TO DEMONSTRATION OF THE SYSTEM, THE UNIT WAS FOUND TO HAVE BEEN MISHANDLED AND STORED IN THE INCORRECT PACKAGING. THE DEVICE WIRES WERE KINKED AND VISIBLY DAMAGED, AND WOULD NOT WORK WHEN COMBINING THE XENON AND LASER LIGHT. MEDTRONIC'S SUBSEQUENT ANALYSIS OF THE DEVICE'S CONDITION FOUND THAT THE FIBER OPTIC CABLE WAS BURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271969 ↗
• MalfunctionAug 21, 2022Thermal Decomposition of Device; Melted; Smoking; Failure to Fire; Thermal Decomposition of Device; Melted; Smoking; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, THE EQUIPMENT DID NOT ACTIVATE THE LAPAROSCOPIC FLUORESCENCE, IT WAS ATTEMPTED A SECOND AND THIRD TIME AND STILL DID NOT ACTIVATE. THE CONNECTION OF THE CABLE BETWEEN THE XENON LIGHT SOURCE AND THE LASER EQUIPMENT BEGAN TO SMOKE AND A YELLOW INCANDESCENT LIGHT COULD BE SEEN FROM THE AREA THAT WAS SMOKING, ADDITIONALLY THE OPTICAL CABLE SHEATH MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263556 ↗