None 430012Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886874114343), received between Oct 14, 2022 and Sep 23, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Split, Cut or Torn

  It was reported that during a da Vinci assisted gynecology surgical procedure, while placing the Single Port (SP) Sheath it was observed to be damaged. Replacing the sheath with another of the same reference resolved the issue.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864101 ↗
• MalfunctionNov 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT SHEATH WAS NOT FASTENING AND SEEMED TO BE LOOSE. THE CUSTOMER REMOVED IT AND FOUND THAT THE INNER PART WAS TORN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 20701219 ↗
• InjuryJul 11, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19719105 ↗
• MalfunctionJun 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507409 ↗
• MalfunctionApr 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE MONOPOLAR CURVED SCISSOR (MCS) SP SHEATH WAS LEFT AT THE TIP. THE TIP WAS STUCK AND COULD NOT BE REMOVED. A SIMILAR INCIDENT HAD OCCURRED RECENTLY AT THE SAME FACILITY. THE MCS INSTRUMENT WAS REMOVED AND A BACKUP ACCESSORY WAS USED TO PROCEED. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OTHER EVENT DATE OF THE ISSUE OCCURRED ON (B)(6) 2024, WHICH WAS COVERED UNDER PATIENT IDENTIFIER (B)(6), AND OTHER TWO CASES MAY HAVE OCCURRED 1 OR 2 WEEKS BEFORE (B)(6) 2024. THE MCS SHEATH WILL NOT BE RETURNED FOR FURTHER EVALUATION. IT CANNOT BE CONFIRMED IF THE INSTRUMENT HAD ANY DAMAGE, OR IF THE DAMAGE WAS ONLY ASSOCIATED WITH THE SP SHEATH. THE EVENT DATE OF THIS ISSUE OCCURRED ON (B)(6) 2024. THE SP SHEATH WAS USUALLY REMOVED OFF BEFORE CENTRAL REPROCESSING. THE SP SHEATH WAS REMOVED OFF AFTER TAKING OFF THE TIP PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102536 ↗
• MalfunctionMar 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE AND PRIOR TO PORTS PLACEMENT, A SINGLE-PORT (SP) INSTRUMENT SHEATH WAS TORN APART. THE DETACHED PIECE WAS ATTACHED TO THE INSTRUMENT SHAFT. THE CUSTOMER USED MOSQUITO FORCEPS TO REMOVE THE SHEATH PIECE FROM THE INSTRUMENT. THE CUSTOMER STATED THAT THE ISSUE HAPPENED BECAUSE THE SHEATH WAS NOT ATTACHED PROPERLY DUE TO SLIGHT OVERLOADING DURING INSTALLATION. THERE WAS NO DAMAGE TO THE SP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE SP SHEATH WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918873 ↗
• MalfunctionJan 25, 2024Material Fragmentation; Material Fragmentation

  THE SP INSTRUMENT SHEATH WAS AN INCIDENTAL RETURN INCLUDED WITH THE FENESTRATED BIPOLAR FORCEPS WHICH ALLEGES THAT AN INSTRUMENT SHEATH WOULD NOT GO ON, AND ANOTHER WAS FOUND WITH A LOOSE RUBBER RING. THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS ACCESSORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577573 ↗
• MalfunctionJan 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE SP INSTRUMENT SHEATH WAS AN INCIDENTAL RETURN. THERE WAS NO ISSUE REPORTED FOR THIS PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548608 ↗
• InjuryJan 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242444 ↗
• InjuryJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A FRAGMENT FELL INTO THE PATIENT¿S CAVITY, BUT THE CUSTOMER WAS NOT AWARE OF THE ISSUE. AFTER REMOVING ALL THE INSTRUMENTS AND ACCESSORIES, THE CUSTOMER CONFIRMED THAT THE FRAGMENT FELL FROM THE INSTRUMENT SHEATH. THERE WAS NO STRONG MOVEMENT THAT WOULD CAUSE THE ACCESSORY TO FALL. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. ANOTHER SHEATH WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CUSTOMER CONFIRMED THAT THE FRAGMENT CAME FROM THE INSTRUMENT SHEATH AFTER USING IT FOR 20-30 MINUTES. THE INVOLVED INSTRUMENTS WOULD NOT BE RETURNED. THE FRAGMENT WAS RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURE AND POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SHEATH WAS PROPERLY INSTALLED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. IN ADDITION, THE FRAGMENT DID NO

  Patient problems: Foreign Body In Patient

  MAUDE report 16218681 ↗
• InjuryOct 14, 2022Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS NOT ABLE TO REMOVE THE SINGLE PORT (SP) CAMERA INSTRUMENT FROM THE STERILE ADAPTER. THE SP INSTRUMENT SHEATHS AND SP CAMERA SHEATH WERE DAMAGED DURING SURGERY FROM RUBBING ON THE CLAMP OF THE ACCESS PORT, SMALL INCISION (INCISION 3CM PORT PLACED BETWEEN ASIS AND THE 12TH RIB), AND PIECES OF THE SHEATHS WERE FLAKING OFF INTO THE PATIENT. THEREFORE, THE CUSTOMER CHANGED SHEATHS MID-CASE WITH MINOR SURGERY DELAY. THE SURGEON WAS ALSO GETTING ¿INSTRUMENT NOT MOVING AS EXPECTED ERRORS¿ ON INSTRUMENTS DUE TO EXCESSIVE RUBBING OF SHAFTS ON ACCESS PORT CLAMP. THE SURGEON COMPLAINED ABOUT THE CAMERA HORIZON INDICATOR NOT ACTUALLY SHOWING THEM WHERE THE GROUND WAS. THE SURGEON ALSO WANTED MORE ARTICULATION IN THE CAMERA OR A 15 DEGREE ANGLED SCOPE TIP. DURING ABOVE CASES THE CAMERA ALSO RETRACTED TISSUE UP SO WHEN THE CAMERA WAS REMOVED THEY COULD NOT REINSERT IT INTO THE BODY WITH GUIDED TOOL CHANGE. THERE WAS A CONCERN THAT IF THE SURGEON IMMERSED THE CAMERA INTO BLEEDING AND THE CAMERA NEEDED TO BE CLEANED ¿ THERE WOULD BE NO WAY TO REINSERT THE CAMERA PAST THE INCISION AND THE INSTRUMENTS WOULD BE LEFT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611831 ↗