None 430035Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00886874114377), received between Sep 4, 2020 and Sep 23, 2026 — classified as 18 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875979 ↗
• MalfunctionAug 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50386957 ↗
• InjuryAug 12, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted procedure, the tip of the Monopolar Curved Scissors (MCS) detached and fell into the patient; however, it was also reported that the MCS breakage did not result in any fragment falling into the patient. The assistant retrieved the tip and confirmed that all fragments were removed. No patient injury was reported, and no post-operative imaging (e.g., X-ray or ultrasound) was performed to assess for retained fragments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227143 ↗
• MalfunctionApr 23, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973949 ↗
• MalfunctionApr 23, 2026Device Difficult to Setup or Prepare

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961863 ↗
• MalfunctionMar 20, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24655244 ↗
• MalfunctionMar 17, 2026Use of Device Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622198 ↗
• MalfunctionFeb 3, 2026Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24243364 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY MYOMECTOMY SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP WAS DISLOCATED FROM INSTRUMENT AND THE PLASTIC RING WAS SEPARATED FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050499 ↗
• InjuryDec 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP FELL OFF THE INSTRUMENT MANY TIMES AND FELL INTO THE PATIENT. DURING THE SURGICAL TASK OF DISSECTION, A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED BY THE ASSISTANT AND CONFIRMED TO BE RETRIEVED BY CHECKING THAT THE TIP WAS COMPLETE. NO ADDITIONAL PROCEDURE WAS PERFORMED TO RETRIEVE THE FRAGMENT NOR WERE POST OPERATIVE IMAGING TESTS DONE DUE TO THE FALLEN FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP MCS TIP. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE MCS TIP IS AVAILABLE TO BE RETURNED TO ISI. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR VIDEO RECORDING OF THE PROCEDURE WERE AVAILABLE FOR INTUITIVE SURGICAL, INC. (ISI) REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692910 ↗
• InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP KEPT FALLING FROM THE MCS INSTRUMENT. THE MCS TIP FELL INTO THE PATIENT AND WAS 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, AND NO DAMAGE WAS NOTED. THE SURGEON BELIEVED THE INSTRUMENT WAS DAMAGED DURING THE SURGERY; IT WAS USED FOR 5 MINUTES. THE SURGEON NOTICED THAT THE TIP HAD DROPPED. INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR THE HARDWARE MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT DIDN'T FALL INSIDE OF 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. NO DAMAGE WAS NOTED TO THE INSTRUMENT, OR THE CANNULA UPON FINAL REMOVAL. HOWEVER, THE SURGICAL STAFF NOTICED THAT THE CONNECTOR OF THE INSTRUMENT WAS DAMAGED. THE ASSISTANT RETRIEVED ALL FRAGMENTS AND CONFIRMED THAT NOTHING WAS LEFT BEHIND. NO ADDITIONA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291679 ↗
• InjuryMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP BROKE INSIDE OF THE PATIENT. A FRAGMENT FELL INTO 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 NOTHING UNUSUAL WAS NOTED; THE TIP WAS PROPERLY MOUNTED AND FUNCTIONED NORMALLY WHEN TESTED FOR MOVEMENT. THE INSTRUMENT WAS NOT MOVING PROPERLY SO THE ARM WAS WITHDRAWN. AT THAT POINT, THE TIP HAD ALREADY SEPARATED AND REMAINED INSIDE OF THE PATIENT WHEN THE ARM WAS REMOVED. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE INSTRUMENT'S BREAKING. THE CUSTOMER DID NOT RECALL HOW LONG THE INSTRUMENT WAS IN USE FOR BUT STATED THAT IT WAS NOT USED FOR A LONG TIME. THE SURGEON RECOGNIZED THAT THE TIP HAD SEPARATED AND REMAINED INSIDE OF THE PATIENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSTEAD OF THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE MCS TIP BECAME DISLODGED DURING THE INSTRUMENT REMOVAL. IT IS UNKNOWN

  Patient problems: Foreign Body In Patient

  MAUDE report 21967339 ↗
• InjuryApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP INSTALLED ON AN MCS INSTRUMENT, CAME OFF AND FELL INSIDE THE PATIENT'S BODY. THE CUSTOMER RETRIEVED THE MCS TIP AND TRIED TO PUT IT BACK ON THE MCS INSTRUMENT; HOWEVER, IT DID NOT WORK FOR AN UNSPECIFIED REASON. THEREFORE, THE CUSTOMER REPLACED THE MCS TIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING ABNORMAL WAS NOTED. IT IS UNKNOWN WHAT TASK WAS BE BEING PERFORMED AT THE TIME OF THE EVENT. THE SURGEON STATED THAT THE TIP OF THE MCS INSTRUMENT HAD BECOME STUCK IN THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND THEN IT WAS FORCIBLY REMOVED, WHICH WAS THE CAUSE OF THE MCS TIP INSIDE THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT WAS IN USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE VENT. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. ADDITIONALLY, THE SURGICAL STAFF DID NOT SEE ANY DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930795 ↗
• MalfunctionNov 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COULD NOT BE MOUNTED ON THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20660860 ↗
• MalfunctionSep 10, 2024

  TIP BROKE WHILE USING IN PATIENT. ABLE TO LOCATE AND RETRIEVE BOTH PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179766 ↗
• MalfunctionAug 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957003 ↗
• InjuryJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19812567 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MSC) TIP COVER FELL OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE CAME DURING PREPARATION FOR THE CASE. ALL FRAGMENTS WERE RETRIEVED OUTSIDE OF THE BODY CAVITY. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611818 ↗
• InjuryMay 7, 2024Detachment 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 CUSTOMER REPORTED THE MONOPOLAR CURVED SCISSORS (MCS) TIP CAME OFF INSIDE THE PATIENT DURING THE CASE. THE PROCEDURE WAS COMPLETED. 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: Foreign Body In Patient

  MAUDE report 19265152 ↗
• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT NIPPLE-SPARING MASTECTOMY WITH IMPLANT RECONSTRUCTION SURGICAL PROCEDURE, THERE WERE TWO INSTANCES OF THE SP MONOPOLAR CURVED SCISSORS (MCS) TIP DISENGAGING AFTER A COLLISION WITH THE FENESTRATION OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE SURGEON RECOGNIZED THE TIP DISENGAGED AND THE INSTRUMENT WAS REMOVED. A NEW TIP WAS THEN INSTALLED. THE TIP DID NOT FALL INTO THE PATIENT. THE CASE PROCEEDED AS NORMAL WITH JUST APPROXIMATELY 2 MINUTES OF SHORT DELAY TO INSTALL A NEW TIP ON THE INSTRUMENT FOR EACH INSTANCE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 01-MAY-2024: THERE WAS NO ARCING NOTED. CUSTOMER WILL NOT BE RETURNING THE SP MCS TIP. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235987 ↗
• MalfunctionApr 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY W/O LYMPHADENECTOMY SURGICAL PROCEDURE, THE USER OBSERVED THAT THE TRANSPARENT PART OF THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP WAS TORN AND COULD NOT BE CONNECTED TO THE INSTRUMENT. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS CONTINUED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORIES WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. A PIN GAUGE WAS USED TO INSPECT THE CANNULA. THE CUSTOMER INDICATED THAT ARCING WAS NOT OBSERVED. THE SP MCS TIP ACCESSORY APPEARED TO BE PROPERLY INSTALLED AND DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE SURGICAL PROCEDURE. THE ISSUE WAS IDENTIFIED DURING DISSECTION AND THE CADIERE FORCEPS AND MARYLAND BIPOLAR FORCEPS INSTRUMENT WERE IN USE. THERE WAS NO REPORT OF FRAGMENT(S) FELL INSIDE OF THE PATIENT. A BACKUP PRODUCT WAS USED TO CONTINUE THE PROCEDURE AND THERE WAS NO PATIENT INJURY/HARM. THE INSTRUMENT HAD NO PHYSICAL DAMAGE AND WOULD NOT BE RETURNED TO ISI FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194821 ↗
• InjuryApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SMALL PIECE OF THE TIP BROKE OFF IN THE PATIENT. THE FRAGMENT WAS RETRIEVED SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON USED THE SP ROBOT TO LOCATE THE PLASTIC TIP OF THE SCISSORS. ONCE THEY WERE ABLE TO IDENTIFY THE PIECE, THEY PULLED IT INTO THE ACCESS BALLOON, WHERE IT WAS REMOVED FROM THE ABDOMEN QUICKLY THROUGH THE AIRSEAL PORT. THE TASK BEING PERFORMED WAS INSERTING THE SCISSORS INTO THE ABDOMEN. THE SURGEON IS UNSURE OF THE CAUSE. THE TIP JUST FELL OFF. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE TIP WAS THROWN AWAY. THERE ARE NO PHOTOS OR VIDEOS AVAILABLE. THE PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19160954 ↗
• InjuryOct 24, 2023Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17999885 ↗
• MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962337 ↗
• MalfunctionJun 23, 2023Material Separation; Material Separation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195406 ↗