Single-Site 478090Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00886874113721), received between May 8, 2019 and Jul 27, 2026 — classified as 12 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50016102 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE TIP AND THE TUBE OF THE SINGLE SITE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT BECAME BENT AND SEPARATED, RENDERING IT UNUSABLE. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24783612 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT COVER WAS PEELING OFF. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PEELED COVERINGS OF THE PERMANENT CAUTERY HOOK WERE NOT EXPOSED. NO ARCING. THERE WERE NO SIGNS OF THERMAL DAMAGE AT SITE OF THE BREAKAGE. THE TIP SEPARATED, MAKING CAUTERY FUNCTION IMPOSSIBLE. THERE WAS NO INJURY. IT WAS REPORTED THAT WHILE THE DEVICE WAS CAUTERIZING THE TISSUE, THERE WERE COATING PEELING. THERE WAS NO SEPARATION, BUT THE TIP APPEARED TO WEAKEN, EXHIBITING A MOVEMENT SIMILAR TO WOBBLING. ULTIMATELY, THE TIP DETACHED WHILE REMOVING THE INSTRUMENT FROM THE 5X250 CANNULA, RENDERING IT UNUSABLE.

  Patient problems: Insufficient Information

  MAUDE report 24750914 ↗
• MalfunctionMar 17, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622066 ↗
• InjuryMar 3, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495771 ↗
• InjuryFeb 23, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424438 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF PERMANENT CAUTERY HOOK INSTRUMENT DETACHED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382851 ↗
• MalfunctionJan 22, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24154339 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050495 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000485 ↗
• InjuryJan 7, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995483 ↗
• MalfunctionDec 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE SINGLE SITE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS OBSERVED TO HAVE A BROKEN TIP. THERE WERE NO REPORT OF DETACHMENT AND NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23901420 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, PERMANENT CAUTERY HOOK (PCH) INSTRUMENT TIP WAS BROKEN. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP OF THE PCH WAS NOT DETACHED OR BROKEN OFF.

  Patient problems: Insufficient Information

  MAUDE report 23872954 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS SEPARATED DURING USE. THE USER CONTINUED AND COMPLETED THE PROCEDURE AS PLANNED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT NOTHING WAS MISSING FROM THE INSTRUMENT'S TIP AND NO FRAGMENT THAT FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872851 ↗
• MalfunctionDec 16, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23822944 ↗
• MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822696 ↗
• MalfunctionDec 16, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813378 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23701740 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT BECAME SEPARATED WHILE MAKING AN INCISION IN THE UTERUS. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT THERE WAS NO PIECE OR MATERIAL MISSING AT THE DISTAL END OF THE INSTRUMENT. NO FRAGMENT FELL INSIDE THE PATIENT¿S ANATOMY, AND PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE DEVICE(S) OR PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590747 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE SINGLE SITE PERMANENT CAUTERY HOOK BROKE AT THE SHAFT NEAR THE TIP, EXPOSING THE WIRE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23354857 ↗
• MalfunctionSep 12, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE SINGLE SITE PERMANENT CAUTERY HOOK INSTRUMENT (PCH) WAS FOUND TO HAVE DEFECT CAUTERY FUNCTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043766 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP PART OF PERMANENT CAUTERY HOOK INSTRUMENT WAS NOTED TO BE BENT AND UPON CHECKING, IT WAS FOUND THAT THE TIP PART WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22929009 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, USER NOTICED THAT THE PLASTIC PART WRAPPING THE HOOK TIP WAS BROKEN AFTER 3 USES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE STATEMENT "PLASTIC PART WRAPPING AROUND THE INSTRUMENT'S TIP" REFERRED TO THE WHITE DISTAL TIP. THE ISSUE OF DAMAGED CONDUCTOR WIRE WAS IDENTIFIED DURING INSPECTION PRIOR TO STERILIZATION PACKAGING, AFTER BEING DISPENSED FROM THE WASHER. DURING THE REPROCESSING OF THE INSTRUMENT, NO DAMAGE WAS FOUND DURING THE INITIAL INSPECTION BEFORE PRELIMINARY CLEANING, BUT IT WAS NOT CHECKED AFTER PRELIMINARY CLEANING AND BEFORE BEING PLACED IN THE WASHER, SUGGESTING THAT THE DAMAGE MIGHT HAVE OCCURRED DURING PRELIMINARY CLEANING OR THE WASHING PROCESS. THE WHITE TIP WAS CONFIRMED TO HAVE BROKEN OFF AND DETACHED FROM THE INSTRUMENT. DURING THE LAST USE IN SURGERY, THE INSTRUMENT WAS INSPECTED BEFORE USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTED. NO FRAGMENT FELL INTO THE PATIENT, AND THUS NO RETRIEVAL OR ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. NO POST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684139 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD PHYSICAL DAMAGE WITH BLACK PLASTIC PART OF THE TIP BROKEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED THE SHAFT WAS DAMAGED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND IT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE PATIENT ANATOMY WITH NO PATIENT INJURY. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) WAS ATTACHED FOR ISI TO REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 22474885 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP OF THE 8MM PERMANENT CAUTERY HOOK 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. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE USER CONFIRMED THAT THE TIP WAS BROKEN BUT NOT DETACHED. NO FRAGMENT FELL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY. THERE WAS NO POST-OPERATIVE TESTS PERFORMED. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATIONS AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. NO IMAGES OR VIDEOS ARE AVAILABLE FOR ISI REVIEW. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22392072 ↗