None 430073Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00886874119549), received between Sep 6, 2024 and Sep 23, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 15, 2025Open, Classified

   Access Port System tray may develop cracks potentially resulting in a sterility breach.

   Z-1096-2026 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874368 ↗
• MalfunctionSep 3, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596451 ↗
• InjuryFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT ACCESS PORT BROKE WHERE IT ATTACHES TO THE GLOBE. THE BROKEN PIECE WAS RETRIEVED AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398588 ↗
• InjuryJan 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE OPENED UP AND USED A SINGLE ACCESS SINGLE PORT KIT. WHEN THE SUTURE WENT THROUGH FINE, A PART OF THE FLAP (YELLOW IN COLOR) POPPED OFF AND FELL INTO THE PATIENT. THE STAFF WAS ABLE TO GET IT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959580 ↗
• MalfunctionOct 30, 2025Material Fragmentation; Gas/Air Leak; Material Fragmentation; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ACCESS PORT TORE IN A VISIBLE SPOT. THIS RESULTED IN A SUDDEN LOSS OF INSUFFLATION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE ACCESS PORT WAS NOT EXTENSIVELY INSPECTED AS IT WAS ASSUMED THAT THERE WERE NO DEFECTS. IT WAS INTACT AT THE BEGINNING, AS WE USED IT FOR AROUND 1.5 HOURS WITHOUT ANY PROBLEMS. THE CUSTOMER OPENED A NEW ACCESS PORT TO CORRECT THE ISSUE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426518 ↗
• MalfunctionAug 27, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908179 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER INSERTION OF RETRACTOR RING, THE GLOBE OF ACCESS PORT WAS ATTACHED. UPON INSUFFLATION THE AREA WHERE THE BLUE CAP PORT WAS ON THE GLOBE WAS SEPARATED, BREAKING THE SEAL. IT WAS THEN REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901111 ↗
• MalfunctionAug 5, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22719187 ↗
• InjuryJul 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF THE ACCESS PORT BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22656317 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE ACCESS PORT WOUND RETRACTOR LARGE RING BROKE OFF DURING REPOSITION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE CUSTOMER, THE INCIDENT RESULTED IN A LOSS OF PNEUMOPERITONEUM DUE TO AN ACCESS PORT ISSUE; HOWEVER, THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 22636552 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A SMALL WHITE CLIP ON THE SP ACCESS PORT KIT THAT ATTACHES THE BOTTOM OF THE ACCESS PORT TO THE WOUND PROTECTOR SNAPPED. THE BREAKING OF THE CLIP CAUSED A RAPID LOSS OF PNEUMOPERITONEUM. THE RAPID LOSS OF INSUFFLATION CAUSED A TEMPORARY LOSS OF VISION AND CONTROL OF THE INSTRUMENTS. NO INJURY OR PATIENT HARM WAS REPORTED. NO FRAGMENT FELL IN THE PATIENT. NO BLEEDING WAS REPORTED. NO COLLISIONS WITH INSTRUMENTATION OCCURRED. THE ACCESS PORT KIT WAS REPLACED WITH A BACKUP ACCESS PORT KIT . SHORTLY AFTER EXCHANGING THE ACCESS PORT KIT, THE SAME SMALL WHITE CLIP SNAPPED AGAIN ON THE REPLACEMENT. THE BREAKING OF THE CLIP CAUSED A RAPID LOSS OF PNEUMOPERITONEUM. THE RAPID LOSS OF INSUFFLATION CAUSED A TEMPORARY LOSS OF VISION AND CONTROL OF THE INSTRUMENTS. NO INJURY OR PATIENT HARM WAS REPORTED. NO FRAGMENT FELL IN THE PATIENT. NO BLEEDING WAS REPORTED. NO COLLISIONS WITH INSTRUMENTATION OCCURRED. THE SURGEON PLACED A LARGE SURGICAL CLAMP ON THE ACCESS PORT KIT TO HOLD THE PNEUMOPERITONEUM AND COMPLETED THE CASE ROBOTICALLY. NO PHOTOS OR VIDEOS OF THE PROCEDURE ARE AVAILABLE FOR REVIEW. BOTH ACCESS PORT KITS WERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133390 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SMALL WHITE CLIP OF THE ACCESS PORT KIT, WOUND PROTECTOR ACCESSORY THAT ATTACHES THE BOTTOM OF THE ACCESS PORT TO THE WOUND PROTECTOR SNAPPED. THE BREAKING OF THE CLIP CAUSED A RAPID LOSS OF PNEUMOPERITONEUM. THE RAPID LOSS OF INSUFFLATION DID CAUSE A TEMPORARY LOSS OF VISION AND CONTROL OF THE INSTRUMENTS. NO INJURY OR PATIENT HARM WAS REPORTED. NO FRAGMENT FELL IN THE PATIENT. NO BLEEDING WAS REPORTED. NO COLLISIONS WITH INSTRUMENTATION OCCURRED. THE ACCESS PORT KIT, WOUND PROTECTOR ACCESSORY WAS REPLACED WITH A BACKUP ACCESS PORT KIT, WOUND PROTECTOR ACCESSORY. SHORTLY AFTER EXCHANGING THE ACCESS PORT KIT, WOUND PROTECTOR ACCESSORY THE SAME SMALL WHITE CLIP SNAPPED AGAIN ON THE REPLACEMENT. THE BREAKING OF THE CLIP CAUSED A RAPID LOSS OF PNEUMOPERITONEUM. THE RAPID LOSS OF INSUFFLATION DID CAUSE A TEMPORARY LOSS OF VISION AND CONTROL OF THE INSTRUMENTS. NO INJURY OR PATIENT HARM WAS REPORTED. NO FRAGMENT FELL IN THE PATIENT. NO BLEEDING WAS REPORTED. NO COLLISIONS WITH INSTRUMENTATION OCCURRED. THE SURGEON PLACED A LARGE SURGICAL CLAMP ON THE ACCESS PORT KIT, WOUND PROTECTOR ACCESSORY TO HOLD T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131913 ↗
• MalfunctionJan 17, 2025Gas/Air Leak; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180436 ↗
• MalfunctionJan 7, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095168 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BEDSIDE ASSISTANT TRIED TO PUSH THE AIRSEAL PORT DEEPER IN TO GET BETTER SMOKE EVACUATION. THE CHAMBER DETACHED FROM THE ACCESS PORT GRIP AND INSUFFLATION WAS LOST. IT WAS AT THE COMPLETION OF THE ROBOTIC PORTION, SO THE TEAM UNDOCKED, COMPLETED THE DISSECTION (ONLY ABOUT 1 CM LEFT AT THIS POINT) AND REMOVED THE SPECIMEN. SINCE THE DISSECTION WAS COMPLETED THE WAY IT WAS SUPPOSED TO BE, THE SURGEON AND THE TEAMS DO NOT CONSIDER THIS AS CONVERSION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, NO FRAGMENT FALL AND NO DELAY. THE PATIENT DID NOT EXPERIENCE ANY IMMEDIATE POST-OPERATIVE COMPLICATIONS PRIOR TO DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067191 ↗
• MalfunctionOct 16, 2024Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458559 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE, THE WOUND RETRACTOR ACCESS PORT WAS FINE ON FIRST SIDE NSM. DURING THE SECOND SIDE, THE PART THAT CLIPS THE ACCESS PORT TOGETHER BROKE OFF AND THE CLIP WAS FOUND ON THE GROUND BY THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE. THERE WAS NO HARM TO THE PATIENT. THE SP ACCESS PORT WILL BE RETURNED THROUGH RETURN MATERIAL AUTHORIZATION (RMA). THE REPORTER DID NOT YET HAVE THE LOT NUMBER TO INITIATE THE RETURN. PER THE INITIAL REPORTER, THERE WAS ISI PERSONNEL PRESENT DURING THE CASE WHO WERE AWARE OF THE MALFUNCTION. THE REPORTER WAS NOTIFIED OF THE EVENT DURING A CASE DEBRIEF CALL. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS FELL INTO THE PATIENT. THE INITIAL REPORTER WAS UNSURE WHICH PORTION BROKE OFF. PATIENT AGE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154302 ↗