VS3-IRRecalls & reported problems across all models

We found 6 models of VS3-IR by Visionsense Ltd. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2021 and Oct 24, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (5 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VS3-IR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 17, 2022Open, 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 ↗

2. Oct 17, 2022Open, Classified

   XXX

   Z-0281-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 17, 2022Open, 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-0280-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported VS3-IR problems

VS3-IR models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VS3-IR 161-0001

  Endoscope, Neurological
  1 recall4 reports
• VS3-IR 174-0012

  Endoscope, Neurological
  1 recall1 report
• VS3-IR 175-0012

  Arthroscope
  1 recall0 reports
• VS3-IR 161-0001

  Confocal Optical Imaging
  4 reports
• VS3-IR 174-0012

  Confocal Optical Imaging
  1 report
• VS3-IR 153-0072

  Laparoscope, General & Plastic Surgery
  1 report

Recent VS3-IR adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO USE, THERE WAS A BROKEN PIECE THAT HAD FALLEN OFF FROM THE DEVICE WHILE MOVING THE LAPAROSCOPIC TOWER FROM AN OPERATING ROOM TO ANOTHER. THERE WAS NO PATIENT INVOLVEMENT. PHOTOS SHOWED CRACK ON THE DEVICE.

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

  MAUDE report 23379055 ↗
• 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 ↗
• MalfunctionApr 14, 2023Thermal Decomposition of Device; Material Integrity Problem; Thermal Decomposition of Device; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE LASER LIGHT SOURCE TURNED ON DURING REGULAR EQUIPMENT TESTS AND THE DAMAGE TO THE CABLE WAS NOTICED. IT WAS ALSO DISPLAYED ON THE ATTACHED VIDEO AND IMAGE. THE AGE OF THE SYSTEM WAS APPROXIMATELY ONE YEAR AGO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743448 ↗
• 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 ↗
• 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 ↗
• 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 22, 2022Thermal Decomposition of Device; Overheating of Device; Smoking; Thermal Decomposition of Device; Overheating of Device; Smoking

  DURING THE BEGINNING OF THE PROCEDURE THE DEVICE WAS WORKING WELL. HOWEVER, AFTER SOME TIME, THE SCOPE BECAME HOTTER AND THE SCOPE FIBER CABLES BEGAN TO BURN AND PRODUCED SMOKE. THERE WAS APPROXIMATELY A 5-10 MINUTE DELAY IN THE PROCEDURE WHILE THE TEAM SWITCHED OUT THE LAP TOWER AND SCOPE FOR ANOTHER ONE. THE OPERATION WAS CARRIED OUT NORMALLY AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271947 ↗
• 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 ↗
• 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 ↗