Single-Site 478093Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00886874113738), received between Dec 23, 2019 and May 14, 2026 — classified as 19 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DETACHED; THE SURGERY WAS IMMEDIATELY CONTINUED AFTER REPLACING IT WITH A BACKUP INSTRUMENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE; THE DETACHED TIP WAS REMOVED IMMEDIATELY, ALL VISUALLY IDENTIFIABLE FRAGMENTS WERE REMOVED (1 FRAGMENT), AND THE PATIENT SHOWED NO ABNORMALITIES. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 5 MINUTES FOR INSTRUMENT REPLACEMENT AND FRAGMENT REMOVAL. THERE WAS NO BLEEDING AND NO PATIENT ABNORMALITIES. THE FRAGMENT REMOVAL WAS COMPLETED AND ENCLOSED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT USED DURING THE SURGICAL PROCEDURE WAS INSPECTED BEFORE USE, WITH NO DAMAGE OR ABNORMALITIES OBSERVED AT THAT TIME. DURING THE SURGERY, A DEVICE FRAGMENT UNEXPECTEDLY FELL INSIDE THE PATIENT; HOWEVER, THERE WAS NO EVIDENCE OF INSTRUMENT COLLISION OR ACCESSORY TIP IMPACT THAT COULD HAVE CAUSED THE ISSUE. THE PRECISE SURGICAL TASK ONGOING WHEN THE FRAGMENT FELL, AS WELL AS THE SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172302 ↗
• MalfunctionMar 10, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, AN OIL-LIKE LIQUID HAD LEAKED FROM THE SURFACE OF THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24554784 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539063 ↗
• MalfunctionMar 4, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF FENESTRATED BIPOLAR FORCEPS BEGAN TO GRADUALLY BECOME MISALIGNED EVEN THOUGH THE TISSUE WAS NOT GRASPED FORCEFULLY. SITE CHECKED, AND THE SCREW THAT HOLDS THE TIP IN PLACE SEEMED WEAK. WHILE REMOVING IT FROM ARM, THE INSTRUMENT GOT STUCK IN TROCAR AND ENTIRE INSTRUMENT WAS REMOVED WITH TROCAR. SAME ISSUE OCCURRED WITH CHANGED INSTRUMENT FROM SAME LOT. SITE USED ANOTHER LOT TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508912 ↗
• MalfunctionJan 8, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE-SITE (SS) FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP BECAME OPEN WHILE SUTURING. 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 CONFIRMED THAT THE JAWS OF THE INSTRUMENT WERE STUCK OPEN DUE TO THE JAW BEING LOOSE. THE INSTRUMENT WAS REMOVED AND CHECKED, AND THE TIP DID NOT FIT, AND THE TIP PART WAS LOOSE. THE CUSTOMER TRIED TO ALIGN THE JAW, BUT IT WOULDN'T FIT, SO THEY STOPPED USING IT TO PREVENT TO FALL THE TIP INSIDE BODY. THE ISSUE DID NOT RESULT IN THE CANNULA BEING REMOVED WITH THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014562 ↗
• MalfunctionJan 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE SITE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A DAMAGED PLASTIC TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23971243 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED DURING THE DA VINCI ASSISTED SURGICAL PROCEDURE; FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS DEFECTIVE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698734 ↗
• MalfunctionOct 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23206481 ↗
• MalfunctionAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER HAD DIFFICULTY IN MOVING SINGLE SITE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. ADDITIONALLY, THE BIPOLAR ENERGY ON INSTRUMENT WAS NOT WORKING. THE INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22928707 ↗
• MalfunctionAug 28, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE SILICONE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WOULD NOT COME OFF. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED AND REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22919198 ↗
• InjuryAug 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. 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 NOTED. 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 MATERIALS. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, AND THE AREA WAS VISUALLY INSPECTED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POSTOPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND, PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THE INSTRUMENT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917138 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S TIP 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. THE CUSTOMER NOTED THE TIP WAS BROKEN OFF. THE INSTRUMENT DID NOT INSTRUMENT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822023 ↗
• MalfunctionAug 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WOULD NOT DETACH FROM THE CANNULA DURING REMOVAL. THE INSTRUMENT WAS EXTRACTED USING THE REMOVAL KEY. THE FRONT TIP OF THE INSTRUMENT WAS BROKEN OFF IN THE PROCESS OF SEPARATING THE INSTRUMENT FROM THE CANNULA. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE IS NO REPORT OF A FRAGMENT FALLING INTO THE PATIENT'S ANATOMY AND ALSO THE PATIENT DID NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

  Patient problems: Insufficient Information

  MAUDE report 22813192 ↗
• InjuryAug 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE TIPS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE MISALIGNED, AND UPON APPLYING GRIPPING PRESSURE, THE INSTRUMENT BROKE, LEADING TO THE BELIEF THAT THE INSTRUMENT WAS DEFECTIVE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND SHOWED NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE INSTRUMENT HAD BEEN IN USE FOR MORE THAN 30 MINUTES BEFORE THE ISSUE OCCURRED. NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS TOOK PLACE. UPON FINAL REMOVAL, THE WRIST WAS STRAIGHTENED, AND NO RESISTANCE WAS FELT THROUGH THE CANNULA, WHICH REMAINED UNDAMAGED. ALL FRAGMENTS WERE IMMEDIATELY RETRIEVED AS THEY FELL IN A VISIBLE AREA, REQUIRING NO ADDITIONAL SURGICAL PROCEDURES FOR REMOVAL. NO POST-OPERATIVE TESTS WERE DEEMED NECESSARY TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND NO POST-SURGICAL COMPLICATIONS RELATED TO A FOREIGN OBJECT HAVE BEEN REPORTED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION, THOUGH THE FRAGMENT CANNOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783506 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE SINGLE-SITE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE THE TIP BROKEN. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE INSTRUMENT TIP WAS BROKEN OFF/DETACHED FROM THE SHAFT. THE REPORTER CLARIFIED THAT THE TIP WAS VISIBLY BROKEN DURING THE PROCEDURE, SPECIFICALLY WHILE COAGULATING A BLEEDING TISSUE. THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND NO FRAGMENT FELL INTO THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY. THERE IS NO REPORT OF POST-SURGICAL COMPLICATIONS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. NO IMAGES OR VIDEOS ARE AVAILABLE FOR ISI REVIEW. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21957982 ↗
• MalfunctionMay 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21954837 ↗
• MalfunctionApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE USER NOTICED THAT THE FENESTRATED BIPOLAR FORCEPS'S JAWS WERE TWISTED AND MISALIGNED. THE USER CONFIRMED NO TISSUE WAS CAUGHT WHEN THE ISSUE OCCURRED. THE INSTRUMENT WAS REMOVED TOGETHER WITH THE CANNULA DUE TO THE MISALIGNED JAWS. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED WITH THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE USER CONFIRMED THAT THE EVENT DATE WAS (B)(6) 2025, THE PORT INCISION WAS NOT INCREASED IN ORDER TO REMOVE THE INSTRUMENT AND CANNULA TOGETHER. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916440 ↗
• MalfunctionMar 13, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT PLASTIC COVER WAS LEFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE ISSUE THAT OCCURRED WAS THAT DURING CENTRAL PROCESSING IT WAS DISCOVERED THAT THE PLASTIC TIP OF THE INSTRUMENT HAD BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT NOR INJURY WHEN THE ISSUE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600106 ↗
• InjuryMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP DETACHED AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE FALLEN TIP FRAGMENT WAS IMMEDIATELY RECOVERED, AND NO VISIBLE DEBRIS WAS NOTED. THE INSTRUMENT WAS REPLACED WITH A BACKUP DEVICE AND THE SURGERY WAS CONTINUED. THE SURGERY WAS DELAYED FOR 10 MINUTES, AND THERE WERE NO ABNORMALITIES IN THE PATIENT. 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 AND NO DAMAGE WAS NOTED. THE SURGEON WAS REMOVING THE UTERUS WHEN THE BROWN PART OF THE INSTRUMENT DETACHED AND THE TIP FELL. IT IS UNKNOWN WHAT THE SURGEON BELIEVES CAUSED THE FRAGMENT TO FALL. THE INSTRUMENT WAS IN USE FOR 20 MINUTES. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES DURING THE PROCEDURE PRIOR TO THE FRAGMENT FALL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588187 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S TIP WAS BROKEN. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21512027 ↗
• MalfunctionMar 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE TIP WAS BROKEN ON A SINGLE SITE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER STATED THAT NO FRAGMENT FELL INTO THE PATIENT AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21501667 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, FENESTRATED BIPOLAR FORCEPS PLASTIC OF THE TIP WAS BROKEN, AND A FRAGMENT FELL INSIDE OF THE PATIENT, THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPE SURGERY. 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 ISSUE WAS NOTED. THE INSTRUMENT WAS IN USE FOR MORE THAN 10 MINUTES. THE TIP WAS NOT MOVED WELL SO THE CUSTOMER CONFIRMED THE INSTRUMENT AND FOUND A CRACK. THE INSTRUMENT WAS REMOVED WITH THE CANNULA. THE INSTRUMENT FULLY BROKE DURING REPROCESSING. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING A SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING INSTRUMENT TIP OR ACCESSORY COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT WAS REMOVED WITH THE CANNULA. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY AND FENESTRATED BIPOLAR FORCEPS WERE USED. NO ADDITIONAL PORTS WERE PLACED OR PORT INCISIONS INCREASED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407986 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD AN EXPOSED WIRE AT THE TIP. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. THE REOCCURRENCE OF THE ALLEGED FAILURE MODE WOULD NOT CAUSE NOR CONTRIBUTE TO AN ADVERSE EVENT OR SERIOUS INJURY. ON (B)(6) 2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: WIRE EXPOSED AT THE END OF THE FENESTRATED BIPOLAR FORCEPS (SEEN ON THE CAMERA). ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS FIRST OBSERVED INTRAOPERATIVELY. IT WAS UNKNOWN IF THE WIRE WAS EXPOSED DUE TO DAMAGED INSULATION. THE CABLE WAS INTACT, THE SCISSOR TIP COVER WAS SPLIT ON THE SIDES. THERE WAS NO LOSS OF CAUTERY ASSOCIATED WITH THE DAMAGED CABLE. IT IS UNKNOWN IF THERE WERE ANY SIGNS OF THERMAL DAMAGE. NO ARCING WAS OBSERVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT, BUT A NEW SCISSOR TIP COVER WAS REPLACED. NO FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT APPEARED TO BE INTACT AND WAS ABLE TO BE USED WITH NEW SCISSORS TIP ACCESSORY. THERE WERE NO INSTRUMENT COLLISIONS THAT OCCURRED DURING THE PROCEDURE. THERE WAS NO IS

  Patient problems: Insufficient Information

  MAUDE report 21271008 ↗
• MalfunctionJan 29, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE DISTAL END OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND BURNT AND DAMAGED. 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 CONFIRMED THAT THE MELTING WAS FOUND WHILE THE INSTRUMENT WAS BEING USED. THE CUSTOMER DID OBSERVE ARCING ORIGINATING FROM THE SUBJECT INSTRUMENT WHILE COAGULATION WAS BEING PERFORMED. THERE WAS NO PATIENT INJURY, THE INSTRUMENT DID NOT COLLIDE WITH OTHERS IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261571 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP PLASTIC WAS FOUND TO BE 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 CUSTOMER NOTED THERE WAS BREAKAGE OF THE INSTRUMENT WHEN REMOVING IT FROM THE TROCAR OUTSIDE THE PATIENT'S BODY WITH NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20414206 ↗