EndoWrist 470405Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00886874115930), received between Mar 3, 2020 and May 22, 2026 — classified as 32 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Break” (36 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0871-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Dec 19, 2024Open, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0872-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT TIP WAS STUCK AND NOT ALIGNED WITH THE REST OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260844 ↗
• MalfunctionMar 13, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT JAWS WERE NOT OPENING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596483 ↗
• MalfunctionFeb 25, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439597 ↗
• MalfunctionJan 15, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087965 ↗
• MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8 MM FORCE BIPOLAR INSTRUMENT HAD A LOT OF "K10250409" BUT NO FAILURE WAS REPORTED. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME WAS NOT PROVIDED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: "I AM UNSURE OF ANY OF THE ANSWERS TO THE OTHER QUESTIONS AS THE INSTRUMENT WAS CLEANED AND RETURNED TO ME WITH NO OTHER INFORMATION. I NOTICED THE WHEEL MISSING ON THE CARTRIDGE AND THAT THE WIRE WIRE/CABLE WAS DISLODGED". THERE WAS A LOOSE CABLE (CABLE DISLODGED BUT STILL INTACT). "THIS WAS SPECIFIED ON THE ORIGINAL RMA, LOOSE WIRE INTACT AND WHEEL MISSING FROM CARTRIDGE". NO MATERIAL MISSING OR DETACHED FROM THE INSTRUMENT AT THE DISTAL END.

  Patient problems: Insufficient Information

  MAUDE report 22946961 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON DISCOVERED THE WRIST OF THE INSTRUMENT WAS KINKED DURING THE PROCEDURE. FA WAS UNABLE TO REMOVE THE INSTRUMENT UNDER NORMAL CIRCUMSTANCES. THEY FINALLY REMOVE IT TOGETHER WITH THE 8MM CANNULA. WHEN THE INSTRUMENT REMOVED FROM THE ARM, THERE WAS A SMALL METAL FOUND AT THE CARRIAGE OF THE ARM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834972 ↗
• MalfunctionOct 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSABDOMINAL PREPERITONEAL (TAPP) UMBILICAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT JAW WAS DISLOCATED. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT DID NOT HAVE ANY PROBLEM ON THE CABLE OR SCREW. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS GRASPING TISSUE AND WAS NOT STUCK IN A CLOSED POSITION AT THE TIME OF THE ISSUE. THE INSTRUMENT WAS REMOVED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17874165 ↗
• InjuryJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FORCE BIPOLAR INSTRUMENT BROKE WHILE IN USE WITHIN THE PATIENT. THE FRAGMENT FELL WHILE REMOVING MESH FROM THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A BACKUP INSTRUMENT DURING THE SAME PROCEDURE. THE FRAGMENT WAS AVAILABLE FOR RETURN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT IMPACT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17136607 ↗
• MalfunctionJun 8, 2023Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FORCE BIPOLAR (FB) INSTRUMENT WAS UNABLE TO CLAMP, THEN UNABLE TO RELEASE. THE CUSTOMER HAD TO USE THE EMERGENCY RELEASE KEY IN ORDER TO REMOVE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE NURSE: "WHILE THEY WERE USING THE INSTRUMENT, PART OF THE TISSUE WAS GETTING TANGLED IN THE WRIST. THE JAWS OF THE BIPOLAR FORCEPS INSTRUMENT LOOKED LIKE IT 'POPPED OUT' AND 'LOCKED UP.'" THEY USED A RELEASE WRENCH TO OPEN THE JAWS. ONCE THEY REMOVED THE INSTRUMENT AND REMOVED ALL THE TISSUE, THEY CONFIRMED NOTHING WAS MISSING FROM THE INSTRUMENT. NO FRAGMENTS FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17095449 ↗
• MalfunctionJun 8, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE CUSTOMER NOTED THE FORCE BIPOLAR INSTRUMENT WOULD NOT RELEASE FROM THE TISSUE. THE CUSTOMER OBSERVED THE INSTRUMENT BECAME SHEARED WHEN REMOVING FROM THE PATIENT. THERE WAS NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR (ROCO) INFORMED THE FORCE BIPOLAR RELEASED THE TISSUE AND NO INJURY OCCURRED. NO FRAGMENTS FELL INTO THE PATIENT. THE ROCO THEN STATED THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC SURGERY BECAUSE HE FELT THE HERNIA REPAIR PROCEDURE WOULD BE EASIER. IT WAS NOTED THAT NO TROUBLESHOOTING WAS CONDUCTED WITH TECHNICAL SUPPORT PRIOR TO THE CONVERSION. THE ROCO CONFIRMED THE PROCEDURE WAS COMPLETED LAPAROSCOPIC WITH NO PATIENT INJURY OR HARM. IN ADDITION, THE OR COORDINATOR INFORMED THAT HE SPOKE TO THE SURGEON WHO INFORMED THAT THE STRONG GRIP MODE WAS ON AT THE TIME OF THE BIPOLAR FORCEPS WAS STUCK ON THE TISSUE. THE ROCO STATED THAT THE SURGEON HAD TO CUT FATTY TISSUE AROUND THE JAWS AND REMOVE THE INSTRUMENT. IT WAS INDICATED THAT THE FATTY TISSUE WAS NOT PART OF THE PLANNED PROCEDURE AND WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093857 ↗
• InjuryJun 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA REPAIR SURGICAL PROCEDURE, THE FORCE BIPOLAR (FB) INSTRUMENT WOULD NOT RELEASE THE TISSUE WHILE SURGEON WAS AT THE CONSOLE. THE CUSTOMER ATTEMPTED TO USE THE EMERGENCY RELEASE KIT; BUT, IT DID NOT WORK. THEREFORE, THE SURGEON CUT THE PIECE OF TISSUE THAT WAS ATTACHED TO THE INSTRUMENT IN ORDER TO REMOVE THE INSTRUMENT FROM THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOW-UP WITH THE CUSTOMER SITE AND RECEIVED THE FOLLOWING INFORMATION FROM THE ROBOTIC LEAD: THE FB INSTRUMENT MALFUNCTIONED DURING THE CASE; THE JAWS WOULD NOT OPEN. BEFORE THE CASE, THE INSTRUMENT WAS INSPECTED AND NOTHING WAS NOTICED. THERE WAS NO INTRA-OPERATIVE COMPLICATIONS OTHER THAN GETTING ANOTHER INSTRUMENT WHICH TOOK ONLY A FEW MINUTES. THE TISSUE THAT WAS TAKEN OUT WITH THE INSTRUMENT WAS PERITONEUM WHICH WAS BEING DISSECTED AT THE TIME. IT WAS CONFIRMED THAT THE SURGEON DID NOT HAVE TO SUTURE THE AREA, IT WAS JUST A VERY SMALL PIECE OF TISSUE. IT IS UNKNOWN IF THE INSTRUMENT WAS IN STRONG GRIP MODE AND IF THE PATIENT HAD ANY PORT-OPERATIVE COMPLICATIONS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A BACKUP FB INSTRUMENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17093841 ↗
• InjuryJun 8, 2023Entrapment of Device; Entrapment of Device

  ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED [USER FACILITY REPORT 2301650000-2020-8010] STATING: A MIDDLE AGED FEMALE PATIENT WHO PRESENTED FOR ELECTIVE ROBOTIC-ASSISTED REPAIR OF INCARCERATED INCISIONAL HERNIA. HAD A HISTORY OF THREE PREVIOUS HERNIA REPAIRS. HER BMI WAS 38 AND HER MEDICAL HISTORY WAS SIGNIFICANT FOR SMOKING, HYPERTENSION, AND DIABETES MELLITUS. DURING HER SURGERY, STAFF WERE UNABLE TO OPEN ONE JAWS OF THE 8MM FORCE BIPOLAR INSTRUMENT. THE INSTRUMENT WAS BEING USED IN CONJUNCTION WITH THE DA VINCI XI ROBOT AND HAD 6 USES LEFT. THE INSTRUMENT HAD BEEN GRASPING TISSUE AT THE TIME OF MALFUNCTION. STAFF ATTEMPTED TO OPEN THE JAWS USING AN EMERGENCY WRENCH BUT WERE UNSUCCESSFUL. THEY CALLED CUSTOMER SERVICE BUT WERE STILL UNABLE TO REMEDY THE SITUATION. THE SURGEON HAD TO CUT SURROUNDING TISSUES TO FREE THE INSTRUMENT FOR REMOVAL. HOWEVER, STAFF WERE ALSO UNABLE TO STRAIGHTEN THE INSTRUMENT SO THAT IT COULD BE REMOVED THROUGH THE TROCAR. THE SURGEON HAD TO EXTEND THE PORT INCISION TO FACILITATE REMOVING THE TROCAR AND INSTRUMENT AS A UNIT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17093840 ↗
• InjuryJun 8, 2023Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WOULD NOT RELEASE FROM TISSUE. THE CUSTOMER STATED THAT THEY HAD TO USE A STAPLER RELEASE KIT (SRK) AND WERE ABLE TO RELEASE THE INSTRUMENT JAWS. THE CUSTOMER REPORTED THAT THE BIPOLAR INSTRUMENT WAS CAUGHT IN THE TROCAR, AND THE BIPOLAR INSTRUMENT AND TROCAR WERE PULLED OUT TOGETHER AS ONE PIECE. THE CUSTOMER ALSO INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY FOUND NO DEBRIS IN THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISSUE OCCURRED WHEN THE SURGICAL STAFF WAS TRYING TO EXCHANGE/REMOVE INSTRUMENTS. THE SCRUB TECHNICIAN WAS UNABLE TO REMOVE THE INSTRUMENT, AND THE SURGEON SCRUBBED BACK IN AND REMOVED THE INSTRUMENT AND CANNULA TOGETHER AS ONE PIECE AFTER THEY UNDOCKED. THE SURGEON LOOKED AROUND TO ENSURE THERE WERE NO OTHER INJURIES OR RETAINED ITEMS IN THE PATIENT. UPON INSPECTION, THE CUSTOMER FOUND SOME PARTS OF THE INSTRUMENT HAD CAUGHT ON THE END OF THE CANNULA, MAKING IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093839 ↗
• MalfunctionJun 6, 2023Premature End-of-Life Indicator; Material Split, Cut or Torn; Premature End-of-Life Indicator; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR EXPIRED PREMATURELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067928 ↗
• MalfunctionJun 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT THE FORCE BIPOLAR INSTRUMENT HAD A MALFUNCTION OF ARM WRIST, A PIECE BULGING OUT INSTEAD OF BEING INTACT THEREBY CAUSING RESTRICTION IN THE ARM MOVEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE FORCE BIPOLAR INSTRUMENT IS A MULTI-USE INSTRUMENT WITH BIPOLAR ENERGY CAPABILITY. THIS INSTRUMENT IS DESIGNED FOR DISSECTION, GRASPING, RETRACTION, AND BIPOLAR COAGULATION OF TISSUE. THIS INSTRUMENT ALLOWS THE USER TO TEMPORARILY APPLY A STRONG GRIP MODE, DEPENDING ON SURGICAL NEEDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067927 ↗
• MalfunctionJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN OR WOULD NOT LOAD. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067921 ↗
• MalfunctionJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT CABLE WAS STRETCHED-OUT. SHE WAS NOT AWARE OF THE COLOR OF THE CABLE OR WHETHER THE INSTRUMENT WAS USED IN THE PROCEDURE, WHETHER THERE WAS ANY CAUTERY OR ARCING ISSUES. SHE CONFIRMED THAT THERE WAS NO FRAGMENT THAT FELL INTO THE PATIENT AND NO INJURY TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067920 ↗
• MalfunctionJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR DID NOT MOVE. THE CUSTOMER REMOVED THE INSTRUMENT TO CHECK AND FOUND THAT THE METAL TIP COVERING THE WIRE CAME OUT AND DID NOT OPEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH ANOTHER INSTRUMENT. 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 BEING USED FOR DISSECTING THE TISSUE, THEN THE METAL COVER OF THE SILVER WIRE WAS DISLODGED. NO LOSS OF CAUTERY OR DAMAGE NOTICED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO SIGNS OF THERMAL DAMAGE OBSERVED. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, AND THERE WAS NO REPORTED PATIENT INJURY. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) WAS PROVIDED FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067918 ↗
• MalfunctionJun 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PART OF THE INSTRUMENT WHERE THE SHAFT AND THE WRIST MEET, WAS BENT AND BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038485 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE FORCE BIPOLAR INSTRUMENT WOULD NOT OPEN. WHEN REMOVING, THE INSTRUMENT GOT STUCK ON THE TROCAR. THE TROCAR WAS PULLED OUT TO REMOVE THE INSTRUMENT. IT WAS NOTED THERE WAS NO PATIENT HARM AND A NEW PRODUCT WAS OPENED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. PER MEDWATCH RECEIVED ON 03/11/2020: FORCE BIPOLAR WOULD NOT OPEN. WENT TO REMOVE AND GOT STUCK ON TROCAR. HAD TO PULL OUT TROCAR TO REMOVE INSTRUMENT. NO HARM TO PATIENT. NEW PRODUCT OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016043 ↗
• MalfunctionMay 28, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE. THE FORCE BIPOLAR INSTRUMENT ALLEGEDLY LOCKED ONTO TISSUE, AND WOULD NOT RELEASE THE TISSUE. THE SURGEON WAS ABLE TO FORCEFULLY RELEASE THE TISSUE FROM THE INSTRUMENT. THE CUSTOMER ALSO REPORTED, OF NOTICING THE BROKEN WIRES ON THE INSTRUMENT'S TIP. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE PATIENTS TISSUE. NO FRAGMENT FELL INTO THE PATIENT. THE OR STAFF DECIDED NOT TO USE THE INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016008 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT 45 MINUTES INTO THE CASE, THE FORCE BIPOLAR INSTRUMENT WRIST BECAME OFFSET AND THE JAWS WOULD NOT OPEN. THE CUSTOMER INDICATED THE INSTRUMENT COULD NOT BE REMOVED AND THEN WAS REMOVED WITH THE TROCAR. 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 CHARGE NURSE INFORMED THE REPORTED ISSUE OCCURRED DURING A ROBOTIC HIATAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION. IT WAS NOTED THAT NO TISSUE WAS STUCK INSIDE THE INSTRUMENT JAWS AND NO TISSUE NEED TO BE REMOVED. THE CHARGE NURSE DID NOT KNOW IF THE FORCE BIPOLAR INSTRUMENT WAS IN FORCE GRIP MODE. NO MEDICAL INTERVENTION WAS REQUIRE, NOR WAS BLOOD LOST. THE INSTRUMENT WAS PULLED OUT AND REPLACED. NO FRAGMENTS FELL INTO THE PATIENT. IT WAS NOTED THE PATIENT WAS A 46-YEAR-OLD FEMALE WHO WEIGHED 94.5 KG AND BIRTHDAY IS (B)(6)1974. THE CHARGE NURSE CONFIRMED THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016007 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ILEAL CONDUIT SURGICAL PROCEDURE, THE CUSTOMER NOTED THE FORCE BIPOLAR INSTRUMENTS JAWS WERE NOT CLOSING PROPERLY. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016005 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WOULD NOT RELEASE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT COULD NOT GET REMOVED FROM THE ARM, SO THE CUSTOMER HAD TO PULL OUT THE TROCAR TO REMOVE THE INSTRUMENT FROM THE ARM. NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016004 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON WAS MANIPULATING TISSUE WHEN THE FORCE BIPOLAR INSTRUMENT JOINT BROKE AND WAS STUCK ON THE TISSUE. THE SITE HAD TRIED THE INSTRUMENT RELEASE KIT (IRK) TO OPEN THE INSTRUMENT JAWS BUT WAS NOT ABLE TO. THE SITE ENDED UP MANIPULATING THE STUCK INSTRUMENT JAWS WITH ANOTHER INSTRUMENT TO GET THE JAWS TO OPEN AND WAS ABLE TO GET THE INSTRUMENT OUT. THE SITE CONTINUED WITH THE CASE. THE CUSTOMER WILL SEND BACK THE INSTRUMENT FOR EVALUATION. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE. THE HINGE POPPED OFF WHEN THE INSTRUMENT WAS AT THE MOST LIMIT OF THE WRIST ARTICULATION. NO FRAGMENT FELL INSIDE THE PATIENT AND IT WAS CONFIRMED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016003 ↗