Single-Site 478053Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00886874113585), received between Mar 8, 2022 and Jun 3, 2025 — classified as 10 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (48 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 8MM MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO KEEP THE CLIP IN PLACE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INCIDENT OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP ON A VESSEL OR A TISSUE BUNDLE. THE ISSUE WAS RELATED TO AN UNSUCCESSFUL CLIP APPLICATION. THE SUBJECT CLIP APPLIER WAS USED ONCE DURING THE PROCEDURE. THEY USED A BACK-UP CLIP APPLIER. THE INSTRUMENT WAS SENT BACK.

  Patient problems: Insufficient Information

  MAUDE report 22136862 ↗
• MalfunctionDec 13, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FIRED THE FIRST CLIP AND IT WOULD NOT CLOSE. THERE WAS A LOUD CRUNCH SOUND HEARD AND THE INSTRUMENT WAS REMOVED. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. 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 ISSUE OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP ON A VESSEL OR TISSUE BUNDLE. WHEN THE INSTRUMENT WAS INSERTED VIA GUIDED TOOL CHANGE (GTC), THE SURGEON WENT TO FIRE THE CLIP, BUT THE INSTRUMENT DID NOT CLOSE, AND A VERY LOUD CRUNCHING SOUND WAS HEARD. THE INSTRUMENT WOULD ROTATE BUT WOULD NOT CLOSE OR FIRE. THE WECK HEM-O-LOK MEDIUM-LARGE CLIPS WERE USED WITH THE INSTRUMENT. THE VESSEL OR TISSUE BUNDLE WAS NOT GREATER THAN THE SPECIFIED DIAMETER SUGGESTED IN THE USER MANUAL. THE ISSUE WAS RESOLVED BY USING A NEW CLIP APPLIER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929505 ↗
• MalfunctionMay 2, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 8MM MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAD THE CLIP MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231800 ↗
• MalfunctionMar 26, 2024Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982713 ↗
• MalfunctionDec 31, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT HOLDING THE CLIP. THE CLIP FALLS OUT OF THE CLIP APPLIER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422975 ↗
• MalfunctionDec 4, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER WAS NOT WORKING. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263919 ↗
• MalfunctionNov 27, 2023Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213660 ↗
• MalfunctionOct 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT RELEASE THE CLIP WHEN APPLYING IT ON A CYSTIC ARTERY. THE MEDIUM-LARGE CLIP APPLIER WOULD NOT ENGAGE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 OF THE PATIENT SIDE CART (PSC) AFTER IT WAS REMOVED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED ERROR 22020 ON USM1. THE TSE ASKED THE CUSTOMER TO RESEAT THE DRAPE ON USM1 AND TRIED ANOTHER INSTRUMENT. THE CUSTOMER WAS ABLE TO INSTALL A DIFFERENT INSTRUMENT SUCCESSFULLY ON USM1. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999895 ↗
• MalfunctionSep 29, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM CLIP APPLIER FAILED TO CLAMP HEMO-CLIP PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848684 ↗
• MalfunctionJul 17, 2023Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17338390 ↗
• MalfunctionJul 13, 2023Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321581 ↗
• MalfunctionMay 15, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ENGAGED AND REGISTERED CORRECTLY. WHEN THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS INSERTED FOR THE SECOND TIME, IT WAS GETTING STUCK IN THE TROCAR CAUSING IT TO BREAK AT THE SHAFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER DID NOT HAVE ANY FURTHER INFORMATION ABOUT THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936488 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT PICK UP HEMOCLIPS EFFECTIVELY AND WOULD NOT CLIP TISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926682 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER WAS FOUND TO HAVE THE CLIPPING FUNCTION NOT WORKING. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. A BACK UP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SYSTEM MALFUNCTION. THE PROCEDURE WAS NOT CONVERTED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS FOLLOWING THE SURGICAL PROCEDURE. IT WAS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AND HOW LONG THE PROCEDURE HAD BEEN IN PROGRESS WHEN THE ISSUE OCCURRED. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW. CUSTOMER CONFIRMED THAT THEY DID NOT FIND ANY BROKEN OR LOOSE CABLE. NON-INTUITIVE MOTION WAS NOT OBSERVED. THE ISSUE WITH THE CLIP APPLIER WAS IDENTIFIED PRIOR TO ATTEMPTING TO CLIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926639 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MEDIUM-LARGE CLIP APPLIER INSTRUMENT MALFUNCTIONED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER THINKS THE ISSUE IS WITH THE ARM AND NOT THE INSTRUMENT, BUT SHE IS NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925327 ↗
• MalfunctionMar 22, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM LARGE CLIP APPLIER INSTRUMENT WOULD NOT CLOSE WHEN PROMPTED. THE CUSTOMER TRIED REAPPLYING THE DRAPE, REMOVING AND REPLACING THE INSTRUMENTS WITHOUT RESOLVING THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEDIUM LARGE CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USAGE. THE REPORTED ISSUE OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP ON VESSEL OR TISSUE BUNDLE. THE CLIP APPLIER INSTRUMENT JAWS WERE NOT CLOSING. THE WECK CLIPS AND THE MEDIUM-LARGE SIZE CLIPS WERE USED. THE VESSEL OR TISSUE BUNDLE WAS GREATER THAN THE SPECIFIED DIAMETER PROVIDED IN IFU. THE CUSTOMER USED ANOTHER CLIP APPLIER INSTRUMENT TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592694 ↗
• MalfunctionFeb 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER WAS NOT HOLDING THE CLIP. THE JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UPS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438505 ↗
• MalfunctionFeb 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369780 ↗
• MalfunctionFeb 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE MEDIUM LARGE CLIP APPLIER INSTRUMENT HAD INADEQUATE CLAMP ISSUE AND FAILURE IN RELEASING THE CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE EVENT OCCURRED WHEN THEY WERE CLIPPING THE DUCT AND THE CLIP WAS OPEN BUT IT WOULD NOT RELEASE FROM THE ARM AFTER CLOSING THE CLIP. USER TOOK A NEW INSTRUMENT TO CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369108 ↗
• MalfunctionFeb 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO RELEASE THE CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE EVENT OCCURRED WHEN THEY WERE CLIPPING THE DUCT AND THE CLIP WAS OPEN BUT AFTER CLOSING THE CLIP IT WOULD NOT RELEASE FROM THE TIPS. THE ISSUE WAS NOT RELATED TO THE CLIP APPLIER JAWS REMAINING STATIC/NOT MOVING WHEN SURGEON COMMANDED MOVEMENT. THE ISSUE WAS NOT RELATED TO UNEXPECTED MOTION OF CLIP APPLIER WHILE ATTEMPTING TO CLIP. THE CLIP OPENED AND CLOSED BUT WOULD NOT RELEASE FROM THE TIPS. THAT WAS THE SPECIFIC ISSUE. THEY TOOK A NEW CLIP APPLIER INSTRUMENT TO CONTINUE. NO MEDIA AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367148 ↗
• MalfunctionFeb 2, 2023Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO APPLY THE CLIPS. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. 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 WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE SURGEON COULD NOT APPLY THE MEDIUM-LARGE HEM-O-LOK CLIP ON THE PATIENT PERSISTENTLY. THE ISSUE OCCURRED ON THE 2ND APPLICATION WHEN THE SURGEON ATTEMPTED TO USE THE INSTRUMENT TO CLAMP ON A VESSEL OR TISSUE BUNDLE. THE VESSEL WAS LESS THAN 10 MM IN DIAMETER. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY/HARM. THE ISSUE WAS NOT RELATED TO UNEXPECTED MOTION OF CLIP APPLIER OR NOT MOVING WHEN SURGEON COMMANDED MOVEMENT. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287297 ↗
• InjuryJan 14, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER MANIPULATED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT BUT WAS NOT ABLE TO APPLY THE CLIPS ON THE TISSUE. THE CLIP FELL INTO THE PATIENT¿S CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF DIFFERENT KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE SURGEON COULD NOT APPLY THE WECK HEM-O-LOK MEDIUM-LARGE LIGATING CLIP ON THE VESSEL, SO THE CLIP FELL INTO THE PATIENT. THE ISSUE OCCURRED AS SOON AS THE CUSTOMER STARTED TO USE THE INSTRUMENT. IT WAS NOT RELATED TO CLIP OPENING AFTER CLOSURE OF THE CLIP. THE VESSEL OR TISSUE BUNDLE WAS LESS THAN THE SPECIFIED DIAMETER SUGGESTED IN THE INSTRUCTIONS FOR USE (IFU) (13MM). THE CLIP WAS RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURE AND POST-OPERATIVE TESTS WERE NOT PERFORMED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. UPON FINAL REMOVAL O

  Patient problems: Foreign Body In Patient

  MAUDE report 16169793 ↗
• InjuryJan 9, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ALLEGEDLY WAS UNABLE TO LOCK THE CLIP. THE USER REPLACED TO THE BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE HOSPITAL NURSE: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUE WAS IDENTIFIED. THE INSTRUMENT INITIALLY WORKED. THE INSTRUMENT WAS UNABLE TO APPLY THE CLIP DURING ACTUAL CLIP APPLICATION. THE INSTRUMENT WAS NOT DAMAGED. THE CLIP THAT WAS INTENDED TO BE APPLIED FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122197 ↗
• MalfunctionDec 22, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT PICK UP THE CLIP FROM THE CARTRIDGE AND WOULD NOT LOCK ON TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040226 ↗
• MalfunctionDec 10, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT CLIP WAS NOT FIXED AND THE INSTRUMENT COULD BE CLOSED. THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY WITH A LAPAROSCOPIC CLIP APPLIER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED. WHEN THE SURGEON USED THE INSTRUMENT TO CLAMP ON THE TISSUE BUNDLE, THE CLIP REMAINED INSIDE THE INSTRUMENT. THE ISSUE OCCURRED FOR ONE OR TWO TIMES AND THE CLIP DID NOT FALL INTO THE PATIENT. THE TISSUE BUNDLE WAS LESS THAN 10 MM. THE CUSTOMER DID NOT RETURN THE INSTRUMENT AS THE INSTRUMENT WAS USED AFTERWARDS AND IT WORKED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956083 ↗