None 400180Recalls & reported problems

Summary

The FDA's MAUDE database contains 435 adverse event reports that list this exact device (DI 00886874111048), received between Dec 13, 2017 and Sep 23, 2026 — classified as 145 injuries, 290 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (190 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 435 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Open or Close

  It was reported that during a Vinci-assisted surgical procedure, the Monopolar Curved Scissors (MCS) instrument jaws would not close. Customer undocked the instrument and re-attached it, but it was not recognized. Customer removed the Trocar and forcibly bent the joint to remove the instrument. The procedure was completed with no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865247 ↗
• MalfunctionAug 24, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420155 ↗
• MalfunctionAug 24, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420154 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  It was reported that during a da Vinci-assisted surgical procedure, the scrub nurse reported that the silicone tip of the Tip Cover accessory was ruptured and proceeded to exchange it for a new one. The robotic coordinator reported that this was the fourth Tip Cover from the same lot to exhibit similar damage.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229490 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229489 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229357 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  It was reported that during a da Vinci-assisted surgical procedure, the scrub nurse reported that the silicone tip of the tip cover accessory had been ruptured during installation. The robotic coordinator indicated them to replace it with a new one and complete the surgery as planned.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228303 ↗
• MalfunctionAug 11, 2026Material Separation

  It was reported that during a da Vinci-assisted surgical procedure, the Monopolar Curved Scissor (MCS) Tip Cover Accessory was lost during the removal of the forceps/gripper. A search was conducted in robotic mode, but the MCS Tip Cover Accessory could not be located. The da Vinci system was then undocked and the surgical procedure was converted to conventional laparoscopy, however the MCS Tip Cover Accessory was still not found. Preparations were then made for a laparotomy conversion. Prior to the initiation of the laparotomy conversion, the disposable MCS Tip Cover Accessory was discovered on the floor, which allowed the laparotomy conversion to be avoided. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203074 ↗
• InjuryAug 6, 2026Material Separation

  It was reported that during a da Vinci¿assisted partial nephrectomy, the Tip Cover accessory from the Monopolar Curved Scissors (MCS) was reported to have dislocated into the abdominal cavity. The Tip Cover Accessory was retrieved during the same procedure using laparoscopic forceps. No patient injury was reported. It is unknown whether the MCS instrument collided with other instruments. The Tip Cover Accessory appeared to have been properly installed, with no orange surface visible after installation, and no electrolube or other lubricant was applied prior to installation. Any resistance or difficulty during instrument removal was unknown, and it was also unknown whether any damage to the Tip Cover Accessory, MCS instrument, or cannula was noted after the event. No additional surgical procedure was required to remove the fragment, and no post-operative imaging (e.g., X-ray or ultrasound) was performed to assess for retained fragments. The patient had not returned due to any post-surgical complications related to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155739 ↗
• MalfunctionJul 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50062236 ↗
• InjuryMay 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT¿S BODY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITHOUT COMPLICATIONS DURING THE SAME PROCEDURE. THE CUSTOMER INDICATED THAT EXCESSIVE LUBRICATION MAY HAVE CONTRIBUTED TO THE MCS TIP COVER ACCESSORY DISLODGING. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25294303 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON NOTICED A SMALL PART OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS TORN. IT WAS IMMEDIATELY REMOVED FROM THE CAVITY AND REPLACED WITH ANOTHER ONE TO PREVENT BURNS TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196967 ↗
• InjuryMay 5, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. A PATIENT WHO HAD A CASE ON (B)(6) 2025, RECENTLY TOOK A COMPUTED TOMOGRAPHY (CT) IMAGE AND FOUND THAT SOMETHING LIKE A TIP COVER WAS REFLECTED. IT COULD NOT BE CONFIRMED BY INTRAOPERATIVE X-RAYS, BUT WHEN THE CUSTOMER CHECKED THE INTRAOPERATIVE VIDEO, AND CONFIRMED THE IMAGE OF THE TIP COVER FALLING OFF. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BASED ON THE SURGICAL CASE INVOLVING THE MCS TIP COVER ACCESSORY, THE HOSPITAL PROVIDED A CLEAR EXPLANATION TO THE PATIENT REGARDING THE ACCESSORY¿S STATUS. WITH THE PATIENT¿S INFORMED CONSENT, NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO RETRIEVE THE MCS TIP COVER ACCESSORY; INSTEAD, THE PATIENT IS CURRENTLY UNDER OBSERVATION. THERE IS NO PLAN TO REMOVE OR RETURN THE TIP COVER BECAUSE THE FRAGMENT WAS NOT RETRIEVED AS THE SURGERY WAS NOT PERFORMED. WHETHER THE MCS INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS, IF THE TIP COVER ACCESSORY W

  Patient problems: Foreign Body In Patient

  MAUDE report 25081902 ↗
• MalfunctionApr 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SCISSORS TIP COVER ACCESSORY WAS BROKEN DURING INTRA-OP PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011213 ↗
• MalfunctionApr 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SCISSORS TIP COVER ACCESSORY WAS BROKEN DURING INTRA-OP PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011210 ↗
• MalfunctionApr 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A TEAR WAS SEEN ON THE SCISSORS TIP COVER ACCESSORY DURING INTRA-OP PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011184 ↗
• MalfunctionApr 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP COVER ACCESSORY (DA VINCI XI) TORN INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011178 ↗
• MalfunctionApr 24, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS FOUND TO BE BROKEN. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24989518 ↗
• MalfunctionApr 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAD TEARS IN THE GRAY SECTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973968 ↗
• InjuryApr 13, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCEPS WERE PROPERLY FITTED, BUT WHEN THE SCISSORS WERE REMOVED FROM THE PORT, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF AND REMAINED INSIDE THE PORT. IT 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: DURING THE SURGICAL EVENT, IT REMAINS UNKNOWN HOW THE MCS TIP COVER ACCESSORY WAS RETRIEVED, WHETHER THE MCS INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS, IF ANY LUBRICANT WAS APPLIED BEFORE INSTALLATION, WHETHER THERE WAS DIFFICULTY IN REMOVAL, WHETHER THE INSTRUMENT WRIST WAS STRAIGHTENED PRIOR TO REMOVAL, OR IF ANY IMMEDIATE DAMAGE WAS OBSERVED ON THE ACCESSORY, INSTRUMENT, OR CANNULA. HOWEVER, IT WAS NOTED THAT THE TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO PART OF ITS ORANGE SURFACE VISIBLE AFTER INSTALLATION, WHICH IS CONSISTENT WITH RECOMMENDED PRACTICE FOR ENSURING ELECTRICAL INSULATION AND SAFETY. THE TIP COVER ACCESSORY HAS BEEN RETURNED TO INTUITIVE SURGICAL FOR FURTHER EVALUATION, THOUGH THE ACCOMPANYING MCS INSTRUMENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859356 ↗
• InjuryApr 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC-ASSISTED CYSTECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT LOOSENED WHILE INSIDE THE PATIENT¿S ABDOMEN. THE SCRUB TECHNICIAN NOTICED THE ISSUE IMMEDIATELY, SO THE SURGEON DID NOT ACTIVATE THE INSTRUMENT. THE SCRUB TECHNICIAN THEN REMOVED THE MCS INSTRUMENT, WHICH CAUSED THE TIP COVER ACCESSORY TO DETACH COMPLETELY. HOWEVER, IT IS UNKNOWN IF THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS RETRIEVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT. ON 12-MAR-2026, ISI RECEIVED MEDWATCH REPORT (MDR) WITH REPORT (B)(4) STATING: "WHILE SURGERY WAS IN PROGRESS; ROBOTIC CYSTECTOMY, THE MONOPOLAR SCISSORS ACCESSORY TIP COVER CAME LOOSE WHILE THE INSTRUMENT WAS INSIDE PATIENT'S ABDOMEN. IT WAS NOTICED RIGHT AWAY BY THE SCRUB TECH; THUS, ACTIVATION OF THE MONOPOLAR SCISSORS WAS NOT INITIATED BY SURGEON. THE SCRUB TECH REMOVED THE MONOPOLAR SCISSORS FROM THE ENDOWRIST THAT CAUSED THE TIP TO COME OFF COMPLETELY FROM THE SCISSORS."

  Patient problems: Insufficient Information

  MAUDE report 24818168 ↗
• MalfunctionApr 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP-COVER ACCESSORY WAS FOUND TO HAVE PERFORATIONS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786939 ↗
• MalfunctionApr 3, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR TIP COVER ACCESSORY WAS IDENTIFIED BY THE SURGEON TO HAVE A PERFORATION INTRAOPERATIVELY AND WAS DEEMED TO BE UNUSABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783597 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24783358 ↗
• InjuryApr 3, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER BECAME LOOSE, FALLING INTO THE CAVITY TWICE EVEN AFTER REPOSITIONING. THE MCS TIP COVER WAS TORN. THE PROCEDURE WAS COMPLETED. A FRAGMENT FELL INTO THE PATIENT, HOWEVER IT WAS UNKNOWN IF IT WAS RETRIEVED. 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 24776383 ↗