NONE 470500Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00886874116401), received between Apr 28, 2023 and Sep 23, 2026 — classified as 54 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that during a da Vinci-assisted Radical Transvesical surgical procedure, when the gas hose was connected, the pressure blew out the inlet pin of the Universal Seal. The customer then switched to another Seal, and which blew out again. The customer used another Universal Seal and proceeded with the case. The procedure was completed. No known impact or patient consequence was reported. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: During the procedure, a broken Luer connector caused a slow, partial loss of insufflation with no error messages displayed on the insufflator. The issue was resolved intraoperatively when the Doctor closed the small valve and switched to a replacement seal, which restored normal conditions. The only clinical impact noted was temporarily dim visualization, which returned to normal once the new Seal was connected. There were no patient injuries, and no additional medical intervention was required. The procedure was completed robotically without further complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872474 ↗
• MalfunctionSep 23, 2026Break

  It was reported that during a da Vinci-assisted radical transvesical surgical procedure, when the gas hose was connected, the pressure blew out the inlet pin of the seal; it was then switched to the other seal and it blew out again. The customer used another accessory and proceeded with the case. The procedure was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865034 ↗
• InjurySep 22, 2026Material Split, Cut or Torn

  It was reported that during a da Vinci-assisted partial nephrectomy procedure, a rubber piece from a Universal Seal tore off and fell inside the patient. The customer confirmed that the fragment was retrieved and removed from the patient's abdomen during the same robotic procedure. No patient complications were reported as a result of the event. 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 50857860 ↗
• InjurySep 10, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725049 ↗
• OtherAug 31, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520070 ↗
• MalfunctionAug 21, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382295 ↗
• MalfunctionAug 16, 2026Use of Device Problem

  It was reported that during a da Vinci-assisted surgical procedure, the Universal Seal had an obstruction at the insertion point. The procedure was completing as planned with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263528 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254152 ↗
• InjuryAug 13, 2026Material Fragmentation

  It was reported that during a da Vinci assisted surgical procedure, a piece (fragment) of the Universal Seal valve broke off and fell inside the patient and was retrieved during the same procedure. The customer confirmed that the fragment was "removed with a spoon". No additional surgery was required to remove the fragment. The procedure was completed robotically with no delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237036 ↗
• MalfunctionJul 28, 2026Break; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059991 ↗
• InjuryJun 11, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION PROCEDURE, A SMALL BLACK PIECE FROM THE UNIVERSAL SEAL WAS IDENTIFIED IN THE PATIENT'S PELVIS. THE FRAGMENT HAD REPORTEDLY FALLEN INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER STATED THAT NO DAMAGE TO THE UNIVERSAL SEAL WAS IDENTIFIED PRIOR TO USE. TOWARDS THE END OF THE PROCEDURE, A PIECE OF PLASTIC WAS OBSERVED IN THE PATIENT'S PELVIS. A LAPAROSCOPIC GRASPER WAS ALREADY INSERTED THROUGH ONE OF THE PORTS AT THE TIME. THE SURGEON SUSPECTS THE FRAGMENT MIGHT HAVE BROKEN OFF DURING INSERTION OR WITHDRAWAL OF EITHER A ROBOTIC INSTRUMENT FROM PORT #3 OR #4 OR A LAPAROSCOPIC GRASPER INSTRUMENT. THE FRAGMENTS WERE REMOVED USING A LAPAROSCOPIC GRASPER. AN INSPECTION OF THE UNIVERSAL SEAL CONFIRMED THAT ONLY A SINGLE PIECE HAD BROKEN OFF. NO POSTOPERATIVE IMAGING, SUCH AS X-RAY OR ULTRASOUND, WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PATIENT HAS NOT RETURNED WITH ANY POSTOPERATIVE COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477587 ↗
• MalfunctionJun 8, 2026

  THE CASE WAS A ROBOTIC LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGECTOMY. WHEN THE OBTURATOR WAS PUT THROUGH TROCAR, DR. [REDACTED] SAW THAT A SMALL PORTION OF THE SEAL HAD BROKEN OFF INTO THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 25425813 ↗
• InjuryMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER SUSPECTED THAT A PIECE OF RUBBER BROKE OFF FROM ONE OF TWO UNIVERSAL SEALS AND FELL INTO THE PATIENT'S BODY CAVITY. THE CUSTOMER RETRIEVED THE FRAGMENT USING A ROBOTIC INSTRUMENT DURING THE SAME PROCEDURE. NO POST-OPERATIVE DIAGNOSTIC STUDIES WERE PERFORMED AND NO ADDITIONAL SURGERIES WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204089 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ISUFFLATION SITE CONNECTOR BROKE. 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 IT BROKE DURING PROCEDURE. THE PART OF THE SEAL THAT BROKE DID NOT EFFECT THE INSUFFLATION WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176807 ↗
• MalfunctionMay 14, 2026

  WHILE ON THE ROBOT FOR ROBOTIC LAPAROSCOPIC CHOLECYSTECTOMY, AN INSTRUMENT WAS PLACED IN THE TROCAR FORCEFULLY AND CUT THE RUBBER SEAL OFF THE TROCAR CAP. IT WAS FOUND IN THE ABDOMEN DURING THE PROCEDURE. CONFIRMED AT THE END OF THE CASE WHERE IT CAME FROM AND THAT WE HAD ALL THE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25168185 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY NECK ANASTOMOSIS SURGICAL PROCEDURE, THE AIR INSUFFLATION PORT BROKE OFF WHILE THE INSUFFLATION TUBING WAS IN USE. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117012 ↗
• InjuryApr 22, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BLACK FRAGMENT FROM A UNIVERSAL SEAL CAME OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABOUT ¾ COMPLETED WITH THE PROCEDURE WHEN A PIECE OF THE UNIVERSAL SEAL WAS OBSERVED TO HAVE FALLEN OFF AND WAS VIEWABLE IN THE PATIENT ANATOMY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH NO INJURY OR HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE UNIVERSAL SEAL WAS INSPECTED AND PLACED ON THE TROCAR, WITH NO ABNORMALITIES OBSERVED AT THAT TIME. THE TROCAR, POSITIONED IN ARM #4 (THE SURGEON'S RIGHT ARM), WAS EXCHANGED MULTIPLE TIMES FOR SCISSORS, CLIPS, AND A NEEDLE HOLDER INSTRUMENTS. IT IS UNCLEAR EXACTLY WHEN THE FRAGMENT FELL INTO THE PATIENT. THE UNIVERSAL SEAL WAS IN USE FOR APPROXIMATELY 2 HOURS. THE SURGEON IS UNCERTAIN WHAT CAUSED THE PIECE TO FALL OFF. THE PORT REMAINED IN PLACE UNTIL THE END OF THE PROCEDURE AND FUNCTIONED PROPERLY THROUGHOUT THE PROCEDURE, WITH NO INDICATION OF A SEAL MALFUNCTION. THE FRAGMENT WAS SUBSEQUENTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955873 ↗
• MalfunctionApr 21, 2026Break; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER 4 HOURS OF DOCKING, THE SEAL SPONTANEOUSLY BROKE AT THE THREADED PART. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE RESULTED IN A RAPID LOSS OF INSUFFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944947 ↗
• InjuryApr 14, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE RUBBER COMPONENT OF THE UNIVERSAL SEAL BROKE AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING A DIFFERENT PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24873029 ↗
• MalfunctionApr 13, 2026Material Fragmentation; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL HAD AIR LEAK. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN IF THE EVENT RESULTED IN SUDDEN/RAPID OF INSUFFLATION. A BACKUP UNIVERSAL SEAL WAS USED FOR THE PROCEDURE WITH NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858918 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSUFFLATION TUBE BROKE WHEN IT WAS ATTACHED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851294 ↗
• MalfunctionApr 11, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848775 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL ACCESSORY BROKE OFF INTO THE INSUFFLATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, A PIECE OF THE SEALING CAP BROKE OFF TWICE, CAUSING A RAPID LOSS OF INSUFFLATION. IN BOTH INSTANCES, THE BROKEN PIECE REMAINED INSIDE THE INSUFFLATION TUBING AND DID NOT ENTER THE PATIENT, WITH NO MISSING FRAGMENTS REPORTED. THE FIRST OCCURRENCE WAS IMMEDIATELY NOTICED UPON ATTACHING THE TUBING, AND THE SECOND WAS IDENTIFIED DURING THE PROCEDURE BY THE WHOOSHING SOUND. BOTH ISSUES WERE RESOLVED BY REPLACING THE SEALING CAP OR SWITCHING THE TUBING TO ANOTHER PORT, RESULTING IN MINIMAL PROCEDURAL DELAY (LESS THAN 3 MINUTES). A PHOTO OF THE PIECE FROM THE FIRST INCIDENT WAS AVAILABLE, BUT NO MATERIALS REMAIN FROM THE SECOND INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816036 ↗
• MalfunctionApr 3, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL LUER PORT WHERE THE INSUFFLATION TUBE CONNECTS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781661 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL PORT HAD A MALFUNCTION AND HAD A DAMAGED PART. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780209 ↗