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Single-Site 478055Recalls & reported problems

Intuitive Surgical, Inc. · CADIERE FORCEPS · Class 2

All models of Single-Site (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
20
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00886874113608), received between Mar 7, 2019 and Aug 21, 2025 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 3 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component10
  • Break4
  • Material Fragmentation3
  • Difficult to Remove2
  • Appropriate Device Problem Term/Code Not Available1
  • Material Integrity Problem1
  • Peeled/Delaminated1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Foreign Body In Patient4
  • No Known Impact Or Consequence To Patient2
  • Device Embedded In Tissue or Plaque1
  • Hemorrhage/Blood Loss/Bleeding1
  • Insufficient Information1

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 21, 2025Break; Break

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE 8MM CADIERE FORCEPS INSTRUMENT'S TIP BROKE WHILE GRASPING UTERINE TISSUE. IT HAD 6 USES REMAINING. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22866696 ↗
  • InjuryAug 7, 2025Material Fragmentation; Material Fragmentation

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22737298 ↗
  • InjuryApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE CADIERE FORCEPS BROKE AND FELL INSIDE OF THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. IT IS UNKNOWN WHAT TASK WAS BEING PERFORMED AT THE TIME OF THE DEVICE FRAGMENT FALLING INTO THE PATIENT. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE INSTRUMENT BREAK. THE CUSTOMER WAS NOT SURE IF THE SURGEON NOTICED ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. IT WAS NOT REPORTED THAT THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE CUSTOMER WAS NOT ABLE TO ANSWER IF FRAGMENTS THAT FELL INSIDE OF THE PATIENT WERE RETRIEVED. THE CUSTOMER PERFORMED A VISUAL INSPECTION OF IRRIGATION IN INTRABDOMINAL CAVITY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21902039 ↗
  • InjuryJan 22, 2025Material Fragmentation; Material Fragmentation

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21208630 ↗
  • MalfunctionNov 26, 2024Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS FUNCTIONED PROPERLY. HOWEVER, THE ADAPTER DETACHED FROM THE HOUSING WHEN ATTEMPTING TO REMOVE THE INSTRUMENT. THE CUSTOMER TRIED TO PULL OUT THE INSTRUMENT BUT IT WAS STUCK. THE CUSTOMER REINSERTED THE INSTRUMENT CAUSING THE SHEATH OF THE SHAFT TO TEAR AND BECOME LODGED AT THE END OF THE CANNULA. THE CUSTOMER WAS ABLE TO REMOVE THE INSTRUMENT. THE USER COMPLETED THE PROCEDURE USING A BACKUP CADIERE FORCEPS WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS REMOVED WITH THE CANNULA BUT THERE WAS NO INCREASE IN PORT SIZE TO REMOVE THE INSTRUMENT AND CANNULA TOGETHER. THE INSTRUMENT WAS NOT GRASPING TISSUE WHEN THE ISSUE OCCURRED. AN IRK WAS NOT USED TO REMOVE THE INSTRUMENT. THERE WAS NO INSTRUMENT COLLISION AND NO INJURY TO THE PATIENT.

    Patient problems: Insufficient Information

    MAUDE report 20779920 ↗
  • InjuryNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE CADIERE FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE ROBOTICALLY WITH NO FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED, WHICH WAS CONFIRMED VISUALLY. THE ISSUE OCCURRED DURING DISSECTING. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THERE WAS NO PATIENT INJURY. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATIONS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE SURGEON WAS UNSURE OF WHAT CAUSED THE INSTRUMENT/ACCESSORY TO BREAK OR CAUSED THE FRAGMENT FALLING ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BR

    Patient problems: Foreign Body In Patient

    MAUDE report 20668845 ↗
  • MalfunctionNov 12, 2024Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20662160 ↗
  • InjurySep 27, 2024Break; Break

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED GASTROSTOMY WHILE RETRACTING THE OMENTUM THERE WAS BLEEDING NOTED. THE SMALL AMOUNT OF BLEEDING WAS ADDRESSED WITH THE HARMONIC ACE INSTRUMENT AND THERE WAS NOT A NEED FOR A BLOOD TRANSFUSION. IT WAS DISCOVERED THAT THE JAW OF THE CADIERE FORCEPS WAS BROKEN AND THERE WAS A SHARP PIECE PRESSING AGAINST THE TISSUE. FRAGMENTS OF THE INSTRUMENT DID FALL INTO THE PATIENT BUT WERE SAID TO ALL BE REMOVED WITH VISUAL CONFIRMATION AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 20317318 ↗
  • MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CADIERE FORCEPS INSTRUMENT WAS FOUND TO HAVE THE INSULATION OF THE SHAFT WORN OFF AND PEELED. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT THE ISSUE WAS IDENTIFIED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE THE PROCEDURE AND CONFIRMED THERE WAS NO PIECE/MATERIAL MISSING AT A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END). THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20154306 ↗
  • MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP PART OF THE CADIERE FORCEPS INSTRUMENT WAS REPORTEDLY BROKEN. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT THE INSTRUMENT TIP WAS DETACHED DURING USE, BUT THERE WAS NO FRAGMENT FELL INSIDE OF THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18995605 ↗
  • InjuryOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE THAT THE CADIERE FORCEPS INSTRUMENT BROKE, WHILE GRASPING TISSUE. THE FRAGMENTS WERE RETRIEVED THROUGH THE PATIENT'S VAGINA. THERE WAS NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. NO DAMAGE, NOR ANYTHING OUT OF THE ORDINARY, WAS FOUND. WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT, THE TRAINEE WAS TRYING INSTRUMENT TO MOVE IT. THE SURGEON BELIEVED THAT EXCESSIVE FORCE IN MOVING THE INSTRUMENT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR 1.5 HOURS BEFORE THE ISSUE OCCURRED. NO ISSUES WERE FOUND WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. IT IS BELIEVED THAT THE INSTRUMENT COLLIDED WITH A MONOPOLAR CURVED SCISSORS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. IT IS UNKNOWN IF THE WRIST WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO DAMAGE WAS FOUND TO THE CANN

    Patient problems: Foreign Body In Patient

    MAUDE report 18038481 ↗
  • MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT JAW WAS BROKEN. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE CONNECTION PART OF THE INSTRUMENT TIPS WAS DISLODGED, BUT IT WAS STILL INSTALLED ON THE INSTRUMENT. THERE WAS NO INTRAOPERATIVE COLLISION OR MISUSE INVOLVING THE INSTRUMENT. THE INSTRUMENT OPERATED AS EXPECTED DURING USE. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17846209 ↗
  • MalfunctionAug 28, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS DAMAGED DUE TO COLLISION WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CADIERE FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE PLASTIC PART OF THE INSTRUMENT SHAFT WAS CRACKED DURING PROCEDURE. THE CUSTOMER CONFIRMED THAT ARCING/SPARK WAS NOT OBSERVED AND NO FRAGMENT FELL INSIDE OF THE PATIENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT HAVE ANY DAMAGE AND WOULD NOT BE RETURNED. THERE WAS NO PATIENT INJURY/HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17635761 ↗
  • InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS BROKE AND HAD FRAGMENTS FELL INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENTS AFTER UNDOCKING. 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 FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND THE CUSTOMER WAS ABLE TO MATCH IT WITH THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND WERE REQUIRED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR 20-30 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WASN'T ANYTHING OUT OF THE ORDINARY. THE SURGEON WAS GRASPING TISSUE WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED PRIOR TO TH

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16928159 ↗
  • MalfunctionMay 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP OF THE CADIERE FORCEPS BROKE DURING TISSUE RETRACTION. THE CUSTOMER USED A BACKUP INSTRUMENT OF THE SAME KIND TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16883537 ↗
  • MalfunctionApr 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16812603 ↗
  • InjuryApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A SINGLE-SITE CADIERE FORCEPS INSTRUMENT BROKE INSIDE A PATIENT. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT AN ¿ADVERSE EVENT" HAD OCCURRED AND INDICATED THAT AN INSTRUMENT HAD BROKEN WHILE IN USE INSIDE A PATIENT. THE ISI CSR STATED THAT ALL PIECES WERE RETRIEVED, AND NO OTHER INJURY WAS REPORTED. THE ISI TSE RECOMMENDED THAT THE ISI CSR REQUEST FOR THE CUSTOMER TO RETURN THE FAILED/DAMAGED INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED. 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: Foreign Body In Patient

    MAUDE report 16676082 ↗
  • InjuryJun 24, 2022Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS FOUND TO HAVE THE SCREW SEPARATED WHILE BEING USED FOR SUTURING. THE SCREW FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES THEN BROKE. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND TH

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14810925 ↗
  • InjuryMar 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

    MAUDE report 9827477 ↗
  • MalfunctionMar 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE INSTRUMENT "EXPLODED" AND FRAGMENTS FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT GRASPING TISSUE AT THE TIME. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE CADIERE FORCEPS INSTRUMENT AND CANNULA WERE INSPECTED PRIOR TO USE. THE INSTRUMENT HAD BEEN INSERTED FOR THE FIRST TIME DURING THE PROCEDURE AND THE SURGEON WAS IN THE PROCESS OF TURNING THE INSTRUMENT TO ORIENT IT WHEN IT BROKE. THE INSTRUMENT DID NOT COME INTO CONTACT WITH ANY HARD MATERIAL. AT THE END OF THE PROCEDURE, AN X-RAY WAS PERFORMED TO LOCATE THE FRAGMENTS. ALL FRAGMENTS WERE LOCATED AND REMOVED WITH LAPAROSCOPIC INSTRUMENTS DURING THE SAME PROCEDURE. THE PATIENT HAS NOT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8402066 ↗

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