Single-Site 478080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874113707), received between Nov 27, 2024 and Nov 10, 2025 — classified as 2 injuries, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510695 ↗
• InjurySep 8, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, A FRAGMENT FROM A BIPOLAR MARYLAND INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE CAUSE OF THE FRAGMENT DETACHING IS UNKNOWN. FORTUNATELY, THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND ITS COMPLETE RETRIEVAL WAS VISUALLY CONFIRMED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT, NOR WERE ANY POST-OPERATIVE TESTS, SUCH AS X-RAYS OR ULTRASOUNDS, CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. A BACKUP BIPOLAR MARYLAND INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998469 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE TIP OF THE SINGLE SITE BIPOLAR MARYLAND FORCEPS INSTRUMENT WAS BROKEN. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE TIP WAS BROKEN OFF/DETACHED FROM THE SHAFT. THERE WAS NO PATIENT INJURY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. NO IMAGES OR VIDEO RECORDINGS WERE AVAILABLE FOR ISI REVIEW. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359054 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER OBSERVED THAT THE WRIST PART OF THE BIPOLAR MARYLAND INSTRUMENT WAS BROKEN WHILE THEY WERE SUTURING TISSUE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE WRIST PART WAS NOT DETACHED FROM THE SHAFT AND NO FRAGMENT FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE REPORTER DID NOT KNOW THE INSTRUMENT'S BATCH SEQUENCE NUMBER. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20793839 ↗