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None 470027Recalls & reported problems

Intuitive Surgical, Inc. · ENDOSCOPE · Class 2

Quick summary

This Intuitive da Vinci robotic endoscope has 117 adverse event reports, with 10 injuries and no deaths. Many describe the camera image flipping or reversing during surgery, and some describe the endoscope base falling off or unintended system movement. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
118
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00886874112212), received between Jun 30, 2020 and Sep 30, 2026 — classified as 10 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (39 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 2 reportsJan 2024: 3 reportsFeb 2024: 0 reportsMar 2024: 6 reportsApr 2024: 2 reportsMay 2024: 2 reportsJun 2024: 4 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 2 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 2 reportsMay 2025: 1 reportsJun 2025: 3 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Image Orientation Incorrect39
  • Unintended System Motion15
  • Device Dislodged or Dislocated14
  • Detachment of Device or Device Component8
  • Component Missing6
  • Unintended Movement6
  • Break5
  • Fogging5

Patient problems

  • No Clinical Signs, Symptoms or Conditions94
  • Insufficient Information9
  • No Known Impact Or Consequence To Patient9
  • Hemorrhage/Blood Loss/Bleeding4
  • Full thickness (Third Degree) Burn2
  • Unspecified Tissue Injury2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Laceration(s)1

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Crack

    Patient problems: Insufficient Information

    MAUDE report 50954066 ↗
  • InjuryMay 4, 2026Image Orientation Incorrect; Output Problem

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

    MAUDE report 25070770 ↗
  • MalfunctionMar 11, 2026Image Orientation Incorrect

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE IMAGE INVERTED ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: Insufficient Information

    MAUDE report 24576359 ↗
  • MalfunctionFeb 5, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE 8MM ENDOSCOPE'S BASE FELL OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24269212 ↗
  • MalfunctionJan 6, 2026Image Orientation Incorrect

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23983100 ↗
  • InjuryNov 26, 2025Device Reprocessing Problem; Device Reprocessing Problem

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 23662341 ↗
  • MalfunctionNov 20, 2025Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS TRYING TO ROTATE THE ENDOSCOPE, BUT THE IMAGE WOULD NOT ROTATE. THE CUSTOMER TRIED RE-INSTALLING THE ENDOSCOPE AND POWER CYCLING THE SYSTEM BUT WITH NO IMPROVEMENT. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO CHECK IF THE HASH MARK AND TOUCHSCREEN ENDOSCOPE DEGREE MARK WERE ALIGNED. THE CUSTOMER STATED THAT THE ENDOSCOPE WOULD ROTATE WHEN ITS ORIENTATION WAS CHANGED FROM THE SURGEON SIDE CONSOLE (SSC), BUT THE IMAGE DID NOT CHANGE. THE CUSTOMER THEN MANUALLY ROTATED THE ENDOSCOPE ORIENTATION AND CONTINUED WITH THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23608323 ↗
  • MalfunctionSep 3, 2025Output Problem; Output Problem

    IT WAS REPORTED THAT DURING PROCEDURE A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE HAD A RECOVERABLE ERROR, AND THE IMAGE FLIPPED 180 DEGREES. THE CUSTOMER REMOVED AND REINSTALLED THE ENDOSCOPE, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22956521 ↗
  • MalfunctionJul 24, 2025Crack; Crack

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22593208 ↗
  • MalfunctionJul 1, 2025Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE'S HEAD WAS FREELY SPINNING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE EXHIBITED UNCONTROLLED MOTION AND A FREELY MOVING GREY CLOSURE OUTSIDE THE PATIENT. THERE WAS NO INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22379155 ↗
  • MalfunctionJun 17, 2025Unintended System Motion; Unintended System Motion

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22248277 ↗
  • MalfunctionJun 5, 2025Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THEIR ENDOSCOPE IMAGE WAS INVERTED AFTER POWER CYCLING THE SYSTEM. THE TSE FOUND NO RELATED ERRORS. THE TSE HAD THE CUSTOMER REMOVE THE ENDOSCOPE FROM THE ARM AND CLEAR THE GUIDED TOOL CHANGE WITH THE PORT CLUTCH. THE CUSTOMER REINSTALLED THE ENDOSCOPE AND THE IMAGE ORIENTATION WAS THEN CORRECT. THE CUSTOMER CONTINUED WITH SYSTEM USE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE INFORMED THE SURGERY WAS LOW ANTERIOR RESECTION. THE 30-DEGREE ENDOSCOPE WAS INSTALLED. IT WAS UNKNOWN IF THE SCOPE WAS INSTALLED UPSIDE DOWN. THE SURGEON DID CONFIRM DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. THE INDICATOR ON SCREEN STATED DOWN BUT IMAGE WAS UP. IT WAS UNKNOWN IF THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE STILL ENGAGED/IN-SYNCH/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE SCOPE. IT WAS UNKNOWN IF PRIOR TO START OF THE SCOPE WAS ROTATED 180 DEGREES. THERE WAS NO PATIENT INJURY. THER

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22155449 ↗
  • MalfunctionJun 3, 2025Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS HAD SEVERAL ISSUES. FIRSTLY, THE SIGNAL AND IMAGE WERE LOST IMMEDIATELY WHEN THE CAMERA WAS FLIPPED UP OR DOWN. SECONDLY, THE SURGEON EXPERIENCED A DELAY AND ASYNCHRONY. THIRDLY, THE INFORMATION BAR AT THE TOP OF THE SYSTEM INDICATED THAT THE LEFT EYE'S FIELD OF VIEW WAS LOST. FOURTHLY, THE SCREEN FLICKERED AT RANDOM TIMES DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FIRSTLY, REGARDING THE USE OF THE ENDOSCOPE'S FUNCTIONS, THERE WERE NO ISSUES OR ERROR REPORTS BEFORE THIS INCIDENT. SECONDLY, DURING THE PROSTATECTOMY, THE SURGEON PERFORMED AN UPWARD-LOOKING OPERATION BY FLIPPING THE ENDOSCOPE, WITHOUT ANY REVERSE OPERATIONS. THERE WERE NO INVERTED IMAGES ON THE VIDEO CART; INSTEAD, THE FIELD OF VISION WAS LOST. THIRDLY, THE VISUAL DIRECTION WAS NOT FREELY MOVABLE BUT WAS STILL UNDER MANUAL CONTROL. FOURTHLY, THE ENDOSCOPE COULD BE MOVED FREELY. FIFTHLY, THERE WAS NO PHYSICAL DAMAGE, AND NO PARTS WERE MISSING OR DETACHED AND ENTERED THE PATI

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22138243 ↗
  • MalfunctionMay 20, 2025Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT 30-DEGREE ENDOSCOPE WAS NOT AIMING CORRECTLY AND THE DEGREE WAS OFF. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE IMAGE WAS POINTING IN THE OPPOSITE DIRECTION ON THE SCREEN. IT WAS UNKNOWN IF THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION OR IF THERE WAS REVERSED CONTROL ON THE SYSTEM ARMS. IT WAS UNKNOWN WHEN THE REPORTED ISSUE WAS INITIALLY IDENTIFIED OR HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22055302 ↗
  • InjuryApr 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY, THE CUSTOMER EXPERIENCED AN ERROR AND ALL VISION WITH THE SYSTEM WAS LOST WHILE USING THE 8MM 30-DEGREE ENDOSCOPE. SEVERAL ATTEMPTS WERE MADE TO CLEAN THE ENDOSCOPE CONNECTOR TO NO AVAIL. DUE TO THE UNAVAILABILITY OF A BACK-UP 30-DEGREE ENDOSCOPE, THE PROCEDURE WAS CONVERTED TO A RADICAL NEPHRECTOMY BECAUSE THE PARTIAL NEPHRECTOMY COULD NO LONGER BE PERFORMED SAFELY AND ONCOLOGICALLY CORRECT WITH THE 0-DEGREE ENDOSCOPE THAT WAS AVAILABLE TO CONTINUE. BECAUSE THIS OCCURRED DURING WARM ISCHEMIA, IT WAS NOT POSSIBLE TO CONVERT THE PROCEDURE TO LAPAROSCOPIC DUE TO THE TIME NEEDED TO BRING IN LAPAROSCOPIC TOWERS AND SET UP THE LAPAROSCOPIC INSTRUMENTS. THERE WAS A 150 ML OF BLOOD LOSS FOR THE ENTIRE PROCEDURE, AND BLOOD WAS LOST DUE TO THE LACK OF VISION EXPERIENCED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A GREATER THAN 30-MINUTE PROCEDURAL DELAY. THE SURGEON IS CONCERNED OF LATE RENAL FUNCTION DECLINE BECAUSE OF THE PROCEDURAL MODIFICATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 21865883 ↗
  • MalfunctionApr 17, 2025Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HOUSING DISCS ON THE 30-DEGREE ENDOSCOPE WERE OBSERVED TO HAVE HIGH FRICTION DURING ROTATION. AS A RESULT, THE PICTURE WAS STUCK ON UPSIDE DOWN VIEW AND WOULD NOT RETURN TO NORMAL VISION. ADDITIONALLY, RECOVERABLE FAULTS WERE RECORDED ON TWO ROBOT ARMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE DURING WHICH THE REPORTED ISSUE OCCURRED WAS A ROBOTIC PROSTATECTOMY. THERE WAS NO INJURY TO THE PATIENT AND NO FRAGMENTS FELL FROM THE DEVICE INTO THE PATIENT ANATOMY. THE ISSUE TRIGGERED A SURGICAL PROCEDURE DELAY OF 30-40 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACK-UP ENDOSCOPE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21857636 ↗
  • MalfunctionMar 6, 2025Image Orientation Incorrect; Image Orientation Incorrect

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21542253 ↗
  • MalfunctionOct 23, 2024Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE IMAGE WAS FLIPPED, AND ONLY ONE EYE WAS DISPLAYED. THE CUSTOMER REPLACED THE ENDOSCOPE TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20516861 ↗
  • MalfunctionSep 25, 2024Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT PRIOR TO THE START (POST-ANESTHESIA) OF A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE 8MM ENDOSCOPE HAD THE ENDOSCOPE IMAGE FLIPPED 180 DEGREES. THE TSE HAD THE CUSTOMER CANCEL GUIDE TOOL CHANGE (GTC), WHICH RESOLVED THE ISSUE. THE TSE FOUND THREE ERROR 23003 IN THE LOGS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE PLACED. THERE WAS NO INJURY TO THE PATIENT. THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20304066 ↗
  • MalfunctionSep 19, 2024Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, 30-DEGREE ENDOSCOPE HAD RECOVERABLE ERRORS. THE IMAGE WAS DISTORTED (MIRRORED) AFTER CAMERA WAS RE-INSERTED ONTO THE ARM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING A PROSTATECTOMY. THE IMAGE APPEARED INVERTED/MIRRORED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS, HOWEVER THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE SYSTEM RECOGNIZED THE CORRECT SCOPE BUT WITH RECOVERABLE FAULTS. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. THE REPORTED WAS UNSURE IF AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE SURGEON VIA USER INTERFACE. THE ISSUE WAS RESOLVED BY USING A BACKUP SCOPE TO COMPLETE THE PROCEDURE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY. HOSPITAL DECLINED TO PROVIDE PATIENT DATA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20264114 ↗
  • MalfunctionAug 23, 2024Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER RE-INSERTING THE 30-DEGREE ENDOSCOPE INSTRUMENT BACK IN AN UP POSITION, THE ENDOSCOPE WOULD FLIP TO THE DOWN POSITION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT IS UNSURE WHICH SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE EVENT, BUT IT WAS CONFIRMED THAT THE IMAGE WAS NOT INVERTED, NEVERTHELESS, THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION AS WHEN THE ENDOSCOPE WAS TAKEN OUT FOR CLEANING, ONCE PUT BACK IN AS 30-DEGREE UP (WHICH WAS ITS PRIOR POSITION), ONE ENGAGED, IT WOULD FLIP TO 30-DEGREE DOWN BEFORE BEING PUSHED IN AND USED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS (E.G., MASTER GOES LEFT, INSTRUMENT GOES RIGHT). ALSO, THERE WAS AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA USER INTERFACE, THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE SUCH AS MISSING SCREW(S) OR COMPONENT. THE SAME ENDOSCOPE WAS USED TO COMPLETE THE PROCEDURE, THERE WAS NO SWITCH OF ENDOSCOPES; THE VISION ISSUE DID NOT RESULT IN PATIENT INJU

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20056106 ↗
  • MalfunctionJul 2, 2024Optical Discoloration; Optical Discoloration

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION, THE CUSTOMER HAD DARKNESS OR COLOR ISSUES WITH THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: YES, IT OCCURRED OUTSIDE THE PROCEDURE. NO, THERE WERE NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19652917 ↗
  • MalfunctionJun 28, 2024Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE IMAGE WAS UPSIDE DOWN AND FLIPPED. THE CUSTOMER HAD TO REMOVE AND RESEAT THE ENDOSCOPE MULTIPLE TIMES. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) EXPLAINED THAT THE ISSUE MAY HAVE BEEN DUE TO THE ENDOSCOPE BEING INSTALLED AT A VERTICAL ANGLE AND THE SYSTEM MAY NOT HAVE KNOWN WHICH ANGLE WAS DOWN BECAUSE THE ENDOSCOPE WAS POINTED TOWARD THE FLOOR. THE TSE EXPLAINED THAT REMOVING THE ENDOSCOPE AND PRESSING THE UNIVERSAL SURGICAL MANIPULATOR (USM) CLUTCH BUTTON WOULD TYPICALLY CLEAR OUT THE GUIDED TOOL CHANGE AND ALLOW THE ENDOSCOPE TO BE INSTALLED AGAIN NORMALLY. THE TSE EXPLAINED THAT IF THE POSITION/ANGLE OF THE PHYSICAL ENDOSCOPE WAS POINTING DOWN, BOTH ANGLE UP AND ANGLE DOWN MAY BE POINTING DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19639088 ↗
  • MalfunctionJun 25, 2024Image Orientation Incorrect; Image Orientation Incorrect

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE TURNED OVER AUTOMATICALLY RESULTING IN THE SUDDEN LOSS OF THE FIELD OF VIEW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STOPPED USING THE ENDOSCOPE WHEN THE ERROR OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19608272 ↗
  • InjuryJun 13, 2024Unintended Movement; Unintended Movement

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 19531793 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.