Single-Site; daVinci Si 428093Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874112106), received between Apr 25, 2017 and Oct 7, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTALLED ON ARM 1 WAS STUCK. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE INSTRUMENT JAWS WERE STUCK OPEN AND COULD NOT BE RETRACTED THROUGH THE TROCAR. THE TSE WAS UNABLE TO VIEW THE SYSTEM LOGS. THE TSE HAD THE SURGICAL STAFF REMOVE THE INSTRUMENT INSTALLED ON ARM 2 AND PARTIALLY RETRACT ITS TROCAR FOR VISUALIZATION. THE SURGICAL STAFF ATTEMPTED TO PULL THE INSTRUMENT THROUGH THE TROCAR BUT THE INSTRUMENT JAWS WOULD NOT CLOSE UNDER PRESSURE. THE CSR INFORMED THE TSE THAT ONE OF THE JAW HALVES WAS TWISTED TO THE SIDE. WHILE ATTEMPTING TO REMOVE THE INSTRUMENT, THE TWISTED JAW AND A SCREW REPORTEDLY FELL INSIDE THE PATIENT. THE SURGICAL STAFF WAS EVENTUALLY ABLE TO REMOVE THE INSTRUMENT FROM ITS TROCAR. THE SURGEON THEN ELECTED TO CONVERT FROM A SINGLE-SITE TO A MULTI-PORT DA VINCI-ASSISTED SURGICAL PROCEDURE. THE SURGICAL STAFF WAS ABLE TO RETRIEVE ONE OF THE BROKEN INSTRUMENT PIECES, THE JAW PORTION. HOWEVER, THE SURGICAL STAFF WAS UNABLE TO RETRIEVE THE OTHER SMAL

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9164556 ↗
• MalfunctionOct 2, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, A PIECE OF THE CERAMIC SLEEVE FROM A FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY AND THE SITE PERFORMED AN X-RAY TEST TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6909254 ↗
• MalfunctionOct 2, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, A PIECE OF THE CERAMIC SLEEVE FROM A FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY AND THE SITE PERFORMED AN X-RAY TEST TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6909233 ↗
• MalfunctionOct 2, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, A PIECE OF THE CERAMIC SLEEVE FROM A FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY AND THE SITE PERFORMED AN X-RAY TEST TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6909205 ↗
• MalfunctionApr 25, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, AND NO FURTHER DETAILS HAVE BEEN OBTAINED AS OF DATE OF THIS REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6520930 ↗