VS3-IR 161-0001 (UDI 10884521817555)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521817555), received between Aug 30, 2021 and Oct 17, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Optical Problem; Optical Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT LASER HAD NO OUTPUT FROM BEAM COMBINER- FIBER PINCHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473928 ↗
• MalfunctionJan 31, 2023Material Puncture/Hole; Device Displays Incorrect Message; Material Puncture/Hole; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A LASER FIBER OR PROTECTIVE GLASS CONNECTOR FAULT MESSAGE. THERE WAS NO PATIENT I NVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272310 ↗
• MalfunctionNov 9, 2022Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FIBER OPTIC CONNECTOR OF THE UNIT BROKE, IT CAN STILL BE USED AND WORKS FINE IN LAPAROSCOPIC PROCEDURES, BUT IT WAS STUCK AND COULD NOT BE TAKEN OUT. A VIDEO WAS RECEIVED SHOWING THAT THE FIBER OPTIC CONNECTOR WAS DAMAGED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761155 ↗
• InjuryAug 30, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE HAD A POOR VISIBILITY. WHEN THE DOCTOR ATTEMPTED TO TURN ON THE LASER LIGHT SOURCE, THEY RECEIVED THE ERROR MESSAGE "OPTIC FIBER FAILURE". HE THEN TRIED TWO DIFFERENT SCOPES AND LIGHT CORDS BUT TO NO AVAIL. DUE TO THE DEVICE PROBLEM THEY CONVERTED THE LAPAROSCOPIC PROCEDURE TO OPEN PROCEDURE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES AND THE INCISION EXTENDED DUE TO THE PRODUCT PROBLEM. THERE WERE NO BLOOD LOSS OF 500CC OR MORE, NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. THE SYSTEM'S AGE WAS 11 MONTHS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388602 ↗