Single-Site; daVinci Si 428058Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874111956), received between Oct 23, 2018 and Jul 29, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE PLASTIC PIECE HOLDING THE FUNDUS GRASPER INSTRUMENT JAWS TOGETHER BROKE WHEN THE SURGEON ATTEMPTED TO GRASP A CATHETER. THE JAWS, PLASTIC, AND PIN FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 07/16/2019, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL TERRITORY ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE WITH ROBOTIC AND LAPAROSCOPIC INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED AND THE PATIENT HAD NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. ISI ALSO FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHILE IN ROUTINE USE DURING THE CASE, THE METALLIC TIPS OF THE INSTRUMENT CAME APART. THE SURGEON STATED THAT AFTER RETRIEVAL OF ALL OF THE PIECES IT APPEARS THE PLASTIC HOUSING ON ONE OF THE TWO SIDES HAD FRACTURED, LEADING THE CONNECTING PIN TO FALL OUT AND ONE OF THE TWO GRASPING ENDS TO BECOME DISLODGED. THI

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8837367 ↗
• InjuryOct 23, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE SINGLE-SITE FUNDUS GRASPER INSTRUMENT BROKE INSIDE THE PATIENT. THE CUSTOMER HAD TO PLACE ANOTHER SURGICAL PORT TO RETRIEVE THE BROKEN PIECE FORM THE PATIENT. A C-ARM MEDICAL IMAGING DEVICE WAS USED TO VERIFY ALL FRAGMENTS WERE RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE SINGLE-SITE FUNDUS GRASPER INSTRUMENT WAS USED FOR 5 ¿ 10 MINUTES BEFORE IT BROKE. THE GALLBLADDER WAS REALLY THICK AND HARD TO GRASP. THE SURGEON DOES NOT REMEMBER WHAT TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON CANNOT BE 100% SURE IF THE SINGLE-SITE FUNDUS GRASPER OR THE SINGLE-SITE MONOPOLAR HOOK INSTRUMENTS COLLIDED WITH EACH OTHER DURING THE PROCEDURE. THE SITE HAD TO CREATE ANOTHER PORT ON THE PATIENT BECAUSE THE SURGEON WAS UNABLE TO REACH THE BROKEN PIECES VIA THE SINGLE-SITE PORT. THE FRAGMENTS WERE RETRIEVED VIA A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND BAG THROUGH THE ADDITION

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7997904 ↗