Ion 490206Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00886874121184), received between Mar 12, 2022 and Sep 19, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2026Device Reprocessing Problem

  Patient problems: Insufficient Information

  MAUDE report 50832263 ↗
• MalfunctionAug 18, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310625 ↗
• MalfunctionMay 5, 2026

  WHEN PLUGGED IN THE IMAGE WAS AN OBSTRUCTED IMAGE, PROBE WAS DEFECTIVE. ERROR MESSAGE READ "VISION PROBE ORIENTATION FAILED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080879 ↗
• MalfunctionMar 24, 2026Device Reprocessing Problem

  IT WAS REPORTED DURING CENTRAL PROCESSING, THE PERIPHERAL VISION PROBE HAD LEAK DISTAL TIP. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682770 ↗
• MalfunctionMar 23, 2026Failure to Conduct

  IT WAS REPORTED DURING CENTRAL PROCESSING, THE PERIPHERAL VISION PROBE ION HAD FAILED LEAK TEST. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670010 ↗
• MalfunctionMar 20, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT TWO LIGHT FIBERS WERE OBSERVED PROTRUDING FROM THE DISTAL END OF A VISION PROBE AFTER IT WAS REINSERTED FOLLOWING A BIOPSY. AFTER THE PROCEDURE, THE VISION PROBE WAS REMOVED AND REPROCESSED, DURING WHICH IT FAILED A LEAK TEST. THE FAILURE OF THE LEAK TEST, ALONG WITH THE PROTRUDING FIBERS, INDICATED POTENTIAL DAMAGE TO THE PROBE. THE PROBABLE ROOT CAUSE OF THE FAILURE WAS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO DAMAGE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THE ISSUE WAS RESOLVED BY USING AN ALTERNATE VISION PROBE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646681 ↗
• MalfunctionMar 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE PHYSICIAN PLACED THE VISION PROBE INTO THE CATHETER, AND UPON REACHING THE END, BOTH THE PHYSICIAN AND STAFF OBSERVED A FIBER VISIBLE IN THE VIEW. THE VISION PROBE WAS THEN WITHDRAWN, AND A FIBER WAS NOTED PROTRUDING FROM THE TIP OF THE PROBE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571913 ↗
• MalfunctionMar 10, 2026Device Reprocessing Problem

  IT WAS REPORTED DURING THE DA VINCI SURGICAL PROCEDURE, PERIPHERAL VISION PROBE HAD ERROR CODE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563491 ↗
• MalfunctionFeb 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PERIPHERAL VISION PROBE MALFUNCTIONED. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284450 ↗
• MalfunctionFeb 3, 2026Material Fragmentation

  IT WAS REPORTED THAT AFTER AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT A SMALL METAL PIECE WAS FOUND IN THE BOTTOM OF A TRAY. THE CUSTOMER REPORTED TO BE UNSURE IF IT HAD BROKEN OFF THE CATHETER OR THE PERIPHERAL VISION PROBE. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, INJURY OR PROCEDURAL DELAY. NO FRAGMENT FELL INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS STATED THAT THE PHYSICIAN DID NOT NOTICE ANYTHING OF CONCERN AND WAS NOT AWARE THAT A PIECE OF METAL WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24253917 ↗
• MalfunctionJan 6, 2026Failure to Conduct

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984911 ↗
• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH A PERIPHERAL VISION PROBE. NO FRAGMENT FELL INTO THE PATIENT AND THERE WAS NO REPORT OF PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23753627 ↗
• MalfunctionDec 5, 2025Device Reprocessing Problem; Device Reprocessing Problem

  DURING CENTRAL PROCESSING, IT WAS REPORTED PERIPHERAL VISION PROBE WOULD NOT PASS TEST AND DID NOT WORK WHEN PUT ON ION SYSTEM. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724563 ↗
• MalfunctionDec 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23721979 ↗
• MalfunctionOct 22, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PERIPHERAL VISION PROBE INSTRUMENT KEPT FAILING AND IT WAS UNABLE TO USE. THE DIAGNOSTIC PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361666 ↗
• MalfunctionAug 26, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892128 ↗
• MalfunctionSep 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE CUSTOMER RECEIVED COLORED BARS ON THE BOTTOM MONITOR OF THE ION. THE SYSTEM REPORTEDLY ADVISED THE CUSTOMER TO REATTACH THE PERIPHERAL VISION PROBE ONTO THE ARM. THERE WERE ERROR CODES DURING THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP WITH THE CUSTOMER: THE REPORTED ISSUE OCCURRED OUTSIDE OF A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166712 ↗
• MalfunctionAug 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE 1.5 PERIPHERAL VISION PROBE BROKE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS FELL INTO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL. THE PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035392 ↗
• MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PERIPHERAL VISION PROBE FAILED THE LEAK TEST. THE USER COMPLETED THE DIAGNOSTIC PROCEDURE USING THE SAME SYSTEM. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621481 ↗
• MalfunctionMay 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE IMAGE WAS PRESENT WHEN STARTING THE PROCEDURE AND THEN WHEN STARTING TO DRIVE THERE WAS NO IMAGE. STAFF NOTICED A LONG THICK STRING PROTRUDING FROM THE VISION PROBE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338602 ↗
• MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE VISION PROBE CAME OUT OF THE CATHETER "PULLED APART". THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE VISION PROBE WAS INSPECTED PRIOR TO USE WITH NOTHING NOTED TO BE OUT OF THE ORDINARY. ALTHOUGH THE VISION PROBE WAS PULLED APART, ALL OF THE PIECES WERE INTACT, AND NO FRAGMENTS FELL INSIDE THE PATIENT'S ANATOMY. THE VISION PROBE HAD HIGH TORQUE, GOT STUCK, AND THE WIRES WERE PULLED APART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177768 ↗
• MalfunctionJan 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE VISION PROBE INSTRUMENT FAILED AND HAD TO BE CHANGED OUT. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO PATIENT HARM OR IMPACT WHAT SO EVER. THEY HAD AN ISSUE WHEN CONNECTING THE VISION PROBE WHICH SEEMED MORE OF A CONNECTION ISSUE. THEY UNPLUGGED AND RE PLUGGED AND COULD NOT GET IT TO WORK. THEY USED A BACKUP TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423069 ↗
• MalfunctionFeb 6, 2023Therapeutic or Diagnostic Output Failure

  THE REP COULD NOT GET THE VISION PROBE TO FUNCTION FOR THE PROCEDURE, ATTEMPTED MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303134 ↗
• MalfunctionMar 12, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PERIPHERAL VISION PROBE WAS BROKEN WHILE MOVING THE ARM. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742385 ↗