NOVADAQ and PINPOINT PC9000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00858701006049), received between Feb 26, 2021 and Aug 31, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “No Device Output” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026No Display/Image; Poor Quality Image

  It was reported that the customer had an issue with setting up the picture sharpness and the picture was vanishing during the procedure, that was probably caused due to a camera cable connection problem. The medical procedure was converted to a conventional laparotomy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534175 ↗
• InjuryAug 28, 2026No Display/Image; Poor Quality Image

  It was reported that the customer had an issue with setting up the picture sharpness and the picture was vanishing during the procedure, that was probably caused due to a camera cable connection problem. The medical procedure was converted to a conventional laparotomy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507209 ↗
• MalfunctionApr 22, 2026No Device Output; Overheating of Device

  IT WAS REPORTED THAT LOUD POP NOISE DURING CASE AND IT STOPPED WORKING AND SMELT LIKE SOMETHING WAS BURNING. MY UNDERSTANDING IS THAT IT CAME FROM THE VPI. THEREFORE, THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957016 ↗
• MalfunctionJan 17, 2024No Device Output; Temperature Problem; No Device Output; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530806 ↗
• MalfunctionJan 4, 2023Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT THE USER RECEIVED AN ELECTRICAL SHOCK.

  Patient problems: Electric Shock; Undesired Nerve Stimulation

  MAUDE report 16098456 ↗
• MalfunctionOct 31, 2022Image Display Error/Artifact; Optical Problem; Image Display Error/Artifact; Optical Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 15700410 ↗
• MalfunctionSep 24, 2022Image Display Error/Artifact; Temperature Problem; Image Display Error/Artifact; Temperature Problem

  IT WAS REPORTED THAT THE LIGHT LEAD WAS VERY HOT, INDICATING A THERMAL EVENT. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478593 ↗
• MalfunctionAug 25, 2022Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE LOST IMAGE DURING A PROCEDURE AND COULD NOT BE POWERED BACK ON. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297972 ↗
• MalfunctionAug 18, 2022Failure to Power Up; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE LOST IMAGE AND POWERED OFF DURING A PROCEDURE. THE USERS WERE UNABLE TO GET THE DEVICE TO POWER BACK ON, WHICH RESULTED IN A 15 MINUTE DELAY WHILE A REPLACEMENT WAS BROUGHT IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT OF ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252529 ↗
• MalfunctionMay 25, 2022Use of Device Problem; Temperature Problem

  IT WAS REPORTED THAT THE HANDHELD DEVICE WAS LEFT ON A PATIENT IN ERROR. AS A RESULT, THE LIGHT FROM THE VIDEO PROCESSOR ILLUMINATOR CAUSED A SMALL HOLE TO BE BURNED INTO THE PATIENT DRAPE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496622 ↗
• MalfunctionNov 30, 2021Electrostatic Discharge; Unintended Electrical Shock; Electrostatic Discharge; Unintended Electrical Shock

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELECTRIC SHOCK.

  Patient problems: Electric Shock

  MAUDE report 12896329 ↗
• MalfunctionNov 10, 2021No Device Output; Unintended Electrical Shock; No Device Output; Unintended Electrical Shock

  IT WAS REPORTED THAT THE USER EXPERIENCED ELECTRIC SHOCK.

  Patient problems: Electric Shock; Shock

  MAUDE report 12789401 ↗
• MalfunctionAug 24, 2021Thermal Decomposition of Device; Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

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

  MAUDE report 12363416 ↗
• MalfunctionAug 19, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345955 ↗
• MalfunctionJun 30, 2021Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093067 ↗
• MalfunctionApr 22, 2021No Device Output; Adverse Event Without Identified Device or Use Problem; No Device Output

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710891 ↗
• MalfunctionFeb 26, 2021Poor Quality Image; Output Problem; Poor Quality Image; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 11387790 ↗