Kii® Optical Access System C0Q19Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915115920), received between Nov 5, 2018 and May 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY. EVENT DESCRIPTION: THE RING IN THE MIDDLE CAME OUT OF THE TROCAR. THEY HAD TO RETRIEVE IT OUT OF THE PATIENT. ALL PIECES WERE RETRIEVED. INTERVENTION: REMOVED THE RING OUT OF THE PATIENT, DISPOSED OF THE TROCAR AND USED A NEW ONE. PATIENT STATUS: NO PATIENT INJURY INDICATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210563 ↗
• MalfunctionMay 6, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, THE APPLIED TROCAR EXPERIENCED DEVICE FAILURE WHEN A CLEAR SEAL COMPONENT BECAME DISLODGED FROM THE TROCAR HOUSING AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE FOREIGN OBJECT WAS IDENTIFIED AND RETRIEVED. INTERVENTION: THE FOREIGN OBJECT WAS IDENTIFIED AND RETRIEVED. PATIENT STATUS: NO CLINICAL IMPACT. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107023 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HIATAL HERNIA PROCEDURE. EVENT DESCRIPTION: TROCAR CAME APART. BLACK RUBBER SEAL CAME OUT OF TROCAR. ALL PIECES AND PACKAGING WERE SAVED AND ARE BEING RETURNED. NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 08OCT2025 VIA EMAIL: REF: C0Q19. LOT: 1558047. DURING DR. [NAME]S SECOND XI HIATAL HERNIA YESTERDAY AFTERNOON, THE 8X100MM TROCAR CAME APART. THE BLACK RUBBER SEAL/LINER PULLED OUT OF THE TROCAR. I HAVE SAVED THE TROCAR AND PACKAGING. NO PIECES FELL INTO THE PATIENT. YES, THE ENTIRE SEAL COMPONENT FELL OUT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362585 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC ASSISTED SUPRACERVICAL HYSTERECTOMY, SACROCOLPOPEXY. EVENT DESCRIPTION: PLASTIC WHITE PART BROKE OFF INTO PATIENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE: PATIENT STATUS IS STABLE. THE PLASTIC WHITE PART WAS REMOVED FROM THE PATIENT. TROCAR AND LOOSE PIECE WAS REMOVED FROM PATIENT AND STERILE FIELD, NEW TROCAR WAS OPENED AND PLACED IN PATIENT. A WHITE PLASTIC PIECE FROM INSIDE THE SEAL HOUSING SLID DOWN THE TROCAR AND FELL OUT INTO THE PATIENT. IT WAS THE PIECE INSIDE THE SEAL HOUSING. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. THE ENTIRE SEAL HOUSING DID NOT DETACH. TYPE OF INTERVENTION: TROCAR AND LOOSE PIECE WAS REMOVED FROM PATIENT AND STERILE FIELD, NEW TROCAR WAS OPENED AND PLACED IN PATIENT. PATIENT STATUS: PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201211 ↗
• MalfunctionOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: WE OPENED ANOTHER ONE OF THIS PRODUCTS TODAY, WE PLAYED WITH IT, INTRODUCED THE OBTURATOR IN AND OUT OF THE SEAL, AND NOT LONG ENOUGH, THE CLEAR PIECE CAME OFF THAT EASILY! ADDITIONAL INFORMATION PROVIDED BY USER FACILITY ON 25SEP2024 BY EMAIL: THIS PRODUCT WAS NOT USED ON A PATIENT. ADDITIONAL INFORMATION PROVIDED BY USER FACILITY ON 25SEP2024 BY EMAIL: YES, THE DEVICE IS AVAILABLE FOR RETURN AND I WILL LEAVE IT IN MM OFFICE. THE LOT NUMBER OF THE DEVICE IS NOT AVAILABLE. THE EVENT DATE IS SEPT.17,2024. NOT USED DURING SURGERY. THIS WAS A NEW ITEM FROM THE SHELF WE OPENED TO REPLICATE THE INITIAL REPORTED PRODUCT ISSUE. PATIENT STATUS: NOT PATIENT RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364071 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: DURING PROCEDURE SURGEON AND PA WERE REMOVING TROCAR AND NOTICED THE CLEAR PLASTIC SEAL CAME OUT AND WAS SEEN IN THE ABDOMEN. THEY WERE ABLE TO REMOVE CLEAR PLASTIC SEAL AND RETAINED IN BIOHAZARD BAG. NO PATIENT HARM. PROCEDURE COMPLETED. INTERVENTION: THEY WERE ABLE TO REMOVE CLEAR PLASTIC SEAL. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349161 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: "A DEFECTIVE TROCAR WHERE THE SEAL FELL OUT IN THE PATIENT." ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 26OCT2023 FROM ACCOUNT MANAGER I, APPLIED MEDICAL: THE BLACK SEAL CAME OUT AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE IT. NO PATIENT HARM. INTERVENTION: THE SURGEON WAS ABLE TO RETRIEVE IT. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196811 ↗
• MalfunctionMar 28, 2023Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE REP WAS NOT PRESENT FOR THE CASE. DURING THE PROCEDURE THE PLASTIC FLANGE/LATCH TAB DISLODGED INTO THE PATIENT'S ABDOMEN. IT APPEARS THAT WHEN INSERTING THE BUTTERFLY NEEDLE, THE LATCH TAB DISLODGED. A GRASPER WAS THEN USED THROUGH THE TROCAR AND THAT PUSHED THE FLANGE INTO THE PATIENT'S ABDOMEN. THERE WAS NO PATIENT INJURY AND THE PATIENT IS OKAY. INTERVENTION: THE LATCH TAB WAS REMOVED FROM THE PATIENT. PATIENT STATUS: PATIENT IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632321 ↗
• MalfunctionNov 11, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION: THE DEVICE WAS USED FOR GASTRECTOMY WHEN THE EVENT OCCURRED. "DURING SURGERY USING AN ARTISENTIAL DEVICE AFTER TROCAR INSERTION TO A PATIENT, THE ARTISENTIAL DEVICE WAS TEMPORARILY ATTEMPTED TO BE REMOVED FROM THE TROCAR, BUT IT WAS NOT REMOVED." THERE WERE NO CHANGES IN PATIENT HEALTH RESULTING FROM THE EVENT. "THE SURGERY WAS REPLACED WITH A NEW PRODUCT" IN ORDER TO RESOLVE THE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 02NOV2021 FROM APPLIED MEDICAL REPRESENTATIVE: THE DAMAGE TO THE TROCAR TIP WAS CAUSED BY PULLING THE ARTISENTIAL DEVICE FROM THE TROCAR WITH FORCE. THE ARTISENTIAL DEVICE WAS THE ONLY INSTRUMENTATION USED PRIOR TO THE INCIDENT. INTERVENTION: THE SURGERY WAS REPLACED WITH A NEW PRODUCT. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796824 ↗
• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC SACROCOLPOPEXY. EVENT DESCRIPTION: THE REP WAS NOT PRESENT DURING THE CASE. DURING THE MIDDLE OF THE CASE THE CLEAR PLASTIC COMPONENT, NORMALLY LOCATED ABOVE THE DOUBLE DUCKBILL SEAL IN THE TROCAR, FELL INTO THE PATIENT. THE ENTIRE COMPONENT FELL INTO THE PATIENT. THE INSTRUMENTS BEING USED THROUGH THE TROCAR ARE UNKNOWN. UNKNOWN IF THE COMPONENT WAS DISCOVERED IMMEDIATELY ONCE IT FELL INTO THE PATIENT OR LATER IN THE CASE. THE COMPONENT WAS RETRIEVED FROM THE PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 09NOV2020 FROM APPLIED MEDICAL TEAM MEMBER: "THIS CLEAR PORTION OF THE SEAL PICTURED IS WHAT FELL INTO THE PATIENT DURING THE ROBOTIC ASSISTED SACROCOLPOPEXY. I SPOKE WITH [] AND HE TOLD ME THAT THIS WAS USED AS HIS ASSIST PORT AND A NEEDLE DRIVER WAS BEING USED WHEN THIS HAPPENED. I DO NOT KNOW IF THE TROCAR WAS USED TO FINISH THE CASE OR IF ANOTHER WAS OPENED." INTERVENTION: PIECE REMOVED FROM PATIENT PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683753 ↗
• MalfunctionFeb 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP SACROCOLPOPEXY. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. [NAME] WAS PERFORMING A LAP SACROCOLPOPEXY. HE SAID THEY NOTICED THAT THE ENTIRE CLEAR SHIELD HAD COME OUT AND WAS INSIDE THE PATIENT. THE SHIELD WAS RETRIEVED AND GRABBED ANOTHER TROCAR TO FINISH THE CASE. [NAME] THOUGHT THAT HE SNAGGED THE SEAL GOING BACK AND FORTH WITH THE NEEDLE. THE NEEDLE WAS PASSED BACK AND FORTH AROUND 15 TIMES. THERE WAS NO PATIENT INJURY. THE TROCAR WAS DISCARDED AFTER THE CASE. ADDITIONAL INFORMATION WAS RECEIVED FROM FDA MEDWATCH, MW# 5093044, VIA MAIL ON MARCH 2ND, 2020: EVENT DESCRIPTION: "PLASTIC INSIDE OF TROCAR BROKE OFF AND WAS FOUND IN ABDOMEN DURING PROCEDURE. THE PIECE WAS REMOVED FROM ABDOMEN IMMEDIATELY. TROCAR WAS INSPECTED, REMOVED FROM THE PT AND REPLACED WITH A NEW ONE. PROCEDURES: LAPAROSCOPIC SACRAL COLPOPEXY WITH CYSTOSCOPY. OP. NOTE: "IN THE LEFT LOWER QUADRANT, AN 8 MM AND A 5 MM TROCAR WERE PLACED. WE LATER REPLACED THE 8 MM WITH THE 11 MM TROCAR." FDA SAFETY REPORT ID# (B)(4)." TYPE OF INTERVENTION: REPLACED WITH A NEW TROCAR PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9772149 ↗
• MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: TROCAR WAS BEING USED AS AN ANCILLARY PORT. USING THE CT NEEDLE TO PASS THROUGH THE TROCAR WHEN THE ENTIRE CLEAR SHIELD OVER THE DUCKBILL CAME OFF THROUGH THE TROCAR AND FELL INTO THE PATIENT. THE SHIELD WAS RETRIEVED FROM THE PATIENT. THE TROCAR WAS REPLACED AND THE PROCEDURE COMPLETED. THE DEVICE IS AVAILABLE TO BE RETURNED. INTERVENTION: REPLACED WITH A NEW TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292283 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP HYSTERECTOMY SACROCOLPOPEXY. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE AT THE TIME OF REPORT. INSIDE SEAL TORE AND TWO PIECES FELL INTO THE PATIENT. THE PIECES WERE RETRIEVED FROM THE PATIENT. REP WAS NOT TOLD WHAT PART OF THE SEAL WAS TORN OR THE COLOR OF THE COMPONENT. ASKED WHAT INSTRUMENTATION WAS BEING USED AT THE TIME BUT THE INFORMATION WAS UNKNOWN. IT IS UNKNOWN IF THEY WERE ABLE TO COMPLETE THE CASE WITH THE EVENT DEVICE OR OPENED ANOTHER TROCAR. DEVICE IS AVAILABLE AND WILL BE RETURNED. INTERVENTION: THE PIECES WERE RETRIEVED FROM THE PATIENT. PATIENT STATUS: FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079422 ↗
• MalfunctionNov 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE CLEAR PORTION OF THE INSIDE OF THE TROCAR FELL APART INSIDE OF THE PATIENT¿S PERITONEUM DURING THE PROCEDURE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. A NEW TROCAR WAS TAKEN APART AND THE RETRIEVED PIECES WERE COMPARED TO THE CLEAR PORTION INSIDE THE NEW TROCAR AND WERE FOUND TO BE COMPLETE. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. IT IS UNKNOWN WHAT INSTRUMENTS WERE IN USE AT THE TIME OF THE INCIDENT. NO PATIENT INJURY OCCURRED AND THE EVENT DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038454 ↗