Kii® OPTICAL ACCESS SYSTEM CTR71Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00607915125042), received between Aug 24, 2016 and Nov 3, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC SLEEVE GASTRECTOMY. EVENT DESCRIPTION: WHILE CLOSING WHILE PULLING TROCARS OUT THE TAB CONNECTED TO SEAL HOUSING BROKE OFF AND INTO THE PATIENT. PIECE WAS REMOVED FROM PATIENT. ANOTHER PRODUCT NOT DEEMED NECESSARY. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 28OCT2025: NO LOT NUMBER WAS PROVIDED THE LATCH TAB ON THE CANNULA BROKE OFF AND FELL INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE IT FROM THE PATIENT. I WAS NOT ABLE TO GET A CLEAR ANSWER ON WHETHER THE TAB WAS BEING PINCHED AT THE TIME OF BREAKAGE. INTERVENTION: PIECE WAS REMOVED FROM PATIENT. ANOTHER PRODUCT NOT DEEMED NECESSARY. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458967 ↗
• MalfunctionMay 12, 2021Fracture; Fracture

  PROCEDURE PERFORMED: "LAP SLEEVE GASTRECTOMY" EVENT DESCRIPTION: "PATIENT WEIGHT COULD HAVE BEEN A FACTOR, AS WE WERE DOING A BARIATRIC PROCEDURE. TROCAR SNAPPED IN HALF WHILE DR. [NAME]" "PATIENT IS RECOVERING FROM SURGERY WITH NO ILL-EFFECTS RESULTING FROM THE INCIDENT." NO MATERIALS WERE LEFT IN THE PATIENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07MAY2021 FROM APPLIED MEDICAL ACCOUNT MANAGER: "THE TROCAR SNAPPED UPON ENTRY." "THE CANNULA SNAPPED IN HALF (SPLINTERED) AT ABOUT THE MIDDLE. IT WAS A CTR71 (150MM). PART OF THE CANNULA WAS STILL INSIDE OF THE PATIENTS ABDOMINAL WALL AND WAS DIFFICULT TO RETRIEVE. A NEW TROCAR WAS INSERTED AND THE CASE CONTINUED WITH NO ADDITION ISSUES." INTERVENTION: THE TROCAR WAS REMOVED FROM THE PATIENT. A NEW TROCAR WAS INSERTED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY, "PATIENT IS RECOVERING FROM SURGERY WITH NO ILL-EFFECTS RESULTING FROM THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814367 ↗
• MalfunctionOct 5, 2018Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. CANNULA FRACTURED: REPORT FROM THE SALES REP: AT THE END OF THE SURGERY, WHEN THE CUSTOMER REMOVED THE EVENT TROCAR FROM PATIENT, THE CANNULA WAS FOUND TO BE FRACTURED AT THE MIDDLE POINT. THE FRACTURED CANNULA FELL OFF INSIDE THE ABDOMINAL CAVITY, BUT IT WAS IMMEDIATELY RETRIEVED AND NO PATIENT HARM WAS REPORTED. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE CANNULA WAS FRACTURED. THE SHAPES OF THE DAMAGED PARTS ARE SIMILAR TO EACH OTHER. THE CANNULA TIP WAS DAMAGED. THE UNIT WILL BE RETURNED FOR FURTHER EVALUATION. (B)(4). ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM DISTRIBUTOR ON 25SEP2018: THE PORT WAS NOT USED WITH A ROBOT. THE METHOD OF INSERTION WAS THE HASSON TECHNIQUE WITHOUT A ROBOT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940546 ↗
• MalfunctionSep 27, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC CASE EVENT DESCRIPTION: COMPLAINT RECEIVED VIA FDA MEDWATCH # MW5071535. PER THE EVENT REPORT, "DURING THE ROBOTIC CASE, AFTER THE TROCAR WAS INTRODUCED, 2 BROKEN PIECES WERE FOUND." THERE WAS NO PATIENT INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED. TYPE OF INTERVENTION: UNK. PATIENT STATUS: "THERE WAS NO INJURY TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899121 ↗
• MalfunctionSep 20, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC RP/NODES/ASR EVENT DESCRIPTION: MEDWATCH (B)(4) WAS RECEIVED VIA MAIL ON 23AUG2017 THE PATIENT WAS HAVING SURGERY FOR A ROBOTIC RP/NODES/ASR. THE SURGICAL TECH REMOVED THE ROBOT CAMERA FROM THE OBTURATOR/ TROCAR TO CLEAN IT, BEFORE HE ATTEMPTED TO REINSERT THE CAMERA, THE OUTER CANNULA SNAPPED IN HALF, LEAVING A PORTION STILL IN THE PATIENT AND HALF ATTACHED TO THE ROBOT ARM. THEY WERE ABLE TO REMOVE IT FROM THE ABDOMEN CAREFULLY USING A HEMOSTAT. THE OBTURATOR WAS INSPECTED AND APPEARED TO BE A CLEAN BREAK WITH NO SHARP EDGES OR LOOSE PIECED. PATIENT WAS DISCHARGED HOME (B)(6) 2017. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM CLINICAL DEVELOPMENT, ON 5-SEP-2017 AT 4:25 PM "IT WAS JUST THE CANNULA." TYPE OF INTERVENTION: UNK. PATIENT STATUS: "PATIENT WAS DISCHARGED HOME ON (B)(6) 2017".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881329 ↗
• MalfunctionSep 11, 2017Break; Break

  PROCEDURE PERFORMED: "RECONSTRUCTION OF URINARY BLADDER WITH DA VINCI ROBOTIC SURGERY" EVENT DESCRIPTION: "AFTER 14 HOURS SURGERY, THIS DEVICE WAS USED WITH ENDOSCOPE BUT IT WAS BROKEN IN PATIENT'S BODY SUDDENLY. PLEASE SEE THE ATTACHED PHOTO." TYPE OF INTERVENTION: UNK PATIENT STATUS: "FINE"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856893 ↗
• MalfunctionAug 28, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ESOPHAGECTOMY. EVENT DESCRIPTION: " THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SLEEVE DAMAGED REPORT FROM THE SALES REP LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE WAS PREFORMED. THE TROCAR WAS USED AS CAMERA PORT. DURING REMOVING THE TROCAR FROM THE PATIENT, THE DISTAL END OF THE CANNULA WAS FRAGMENTED AROUND TWO TO THREE INCREMENTS OF THE THREAD DESIGN PART FROM THE DISTAL. THE DISTANCE BETWEEN RIBS WAS NARROWER THAN GENERAL PATIENT'S. OTHER THAN THAT, THE PROCEDURE HAD NO ANOMALY SUCH AS APPLYING AN EXCESSIVE FORCE TO THE TROCAR IN THE CUSTOMER'S TECHNIQUE. THE CUSTOMER WAS UNAWARE OF THE DETAIL ABOUT WHEN THE INCIDENT OCCURRED. FRAGMENTS FELL OFF INSIDE ABDOMINAL CAVITY, BUT THEY WERE REMOVED FROM THE PATIENT. NO INJURY AND LESS BLEEDING. INITIAL INVESTIGATION REPORT BY [DISTRIBUTOR]: THE EVENT UNIT WAS RETURNED TO [DISTRIBUTOR] AND VISUALLY INSPECTED. THE THREADING PART OF THE CANNULA WAS FRAGMENTED(FIG.1). THE THREE FRAGMENTS WERE RETURNED(FIG.2). THE SIZES ARE RESPECTIVELY APPROX. 9.0 MM X 4.0 MM, 4.0 MM X 2.0, 2.0 MM X 1.0 MM. THREE FRAGMENTS MATCHED THE MISSING LOCATIONS ON THE SLEEVE IN SH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6824759 ↗
• MalfunctionAug 21, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: "TRYING TO DOCK THE ROBOT FOR PATIENT PROCEDURE. THE TROCAR BROKE HALFWAY DOWN THE SHAFT. 2 PIECES WERE COLLECTED AND GIVEN TO THE APPROPRIATE TEAM MEMBER. THE TROCAR WAS NOT IN THE PATIENT AT THE TIME" ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON FRIDAY (B)(6) 2017 AT 9:25 AM FROM USER FACILITY: ATTACHED PICTURES SHOWED THAT IT BROKE IN HALF AT THE SHAFT. THE NAME OF THE PROCEDURE IS ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY. WHEN TRYING TO DOCK THE ROBOT FOR PT PROCEDURE THE ITEM BROKE HALF WAY DOWN THE SHAFT, TWO PIECES COLLECTED. LOT # IS 1292159. NOT SURE IF THERE ARE ANY OTHER DEVICES BEING USED AT THE TIME SUCH AS THE SCOPE. THE INCIDENT OCCURRED DURING SURGERY. TYPE OF INTERVENTION: "OPENED ANOTHER TROCAR AND FINISHED THE SURGERY" PATIENT STATUS: "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808881 ↗
• MalfunctionAug 21, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC ASSISTED OPERATIVE LAPAROSCOPY EVENT DESCRIPTION: CER 1 OF 2: 2017-1481 CER 2 OF 2: 2017-1482 "THE TROCAR BROKE WHILE TRYING TO PENETRATE THE ABDOMINAL CAVITY. IT WAS A CLEAN BREAK. BOTH PIECES WERE RECOVERED. PATIENT WAS FINE. THE PIECES FELL IN THE PATIENT BUT BOTH PIECES WERE RECOVERED. THEY COLLECTED THE PIECES AND GAVE IT TO THE APPROPRIATE TEAM MEMBER. THEY OPENED UP A NEW TROCAR AND FINISHED THE PROCEDURE" ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON FRIDAY 28JULY2017 AT 9:25 AM FROM USER FACILITY: ATTACHED PICTURES SHOWED THAT IT BROKE IN HALF AT THE SHAFT. THE NAME OF THE PROCEDURE IS ROBOTIC ASSISTED OPERATIVE LAPAROSCOPY. ITEM USED TO PENETRATE ABDOMINAL CAVITY, SHAFT BROKE IN HALF, BROKEN HALF RETRIEVED FROM ABDOMINAL CAVITY INTACT. LOT # IS 1288495. NOT SURE IF THERE ARE ANY OTHER DEVICES BEING USED AT THE TIME SUCH AS THE SCOPE. TYPE OF INTERVENTION: OPENED UP A NEW TROCAR AND FINISHED THE PROCEDURE . PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808787 ↗
• MalfunctionAug 21, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: "TRYING TO DOCK THE ROBOT FOR PATIENT PROCEDURE. THE TROCAR BROKE HALFWAY DOWN THE SHAFT. TWO (2) PIECES WERE COLLECTED AND GIVEN TO THE APPROPRIATE TEAM MEMBER. THE TROCAR WAS NOT IN THE PATIENT AT THE TIME." TYPE OF INTERVENTION: "OPENED ANOTHER TROCAR AND FINISHED THE SURGERY." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807892 ↗
• MalfunctionAug 8, 2017Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC DUODENAL SWITCH. EVENT DESCRIPTION: "DR. [NAME], CHIEF OF SURGERY AT (B)(6) HOSPITAL, WAS TOWARDS THE END OF HIS LAP DUODENAL SWITCH WHEN A CTR71, USED AS HE NORMALLY WOULD, BROKE AND THE BOTTOM THIRD OF THE CANNULA BROKE CLEAN OFF. THE PATIENT WAS NOT HARMED AND THE BROKEN PORTION OF THE CANNULA WAS RETRIEVED AND IS BEING SENT WITH THE TOP PORTION OF THE CANNULA. BOTH PORTIONS OF CANNULA HAVE BEEN CLEANED BY SPD AND NEED TO BE SENT IN. THIS IS THE SECOND INCIDENT FOR THIS SURGEON WITH THE SAME PRODUCT AND LOT NUMBER." TYPE OF INTERVENTION: NO PATIENT ILLNESS OR INJURY. THE CANNULA WAS RETRIEVED AND IS BEING SENT WITH THE TOP PORTION OF THE CANNULA. PATIENT STATUS: "NO COMPLICATIONS".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6775925 ↗
• MalfunctionJun 15, 2017Break; Break

  PROCEDURE PERFORMED: TURP WITH DA VINCI ROBOTIC SURGERY. EVENT DESCRIPTION: "IN SURGERY, THIS DEVICE WAS USED WITH ENDOSCOPE BUT IT WAS BROKEN IN PATIENT BODY SUDDENLY." PHOTOGRAPH PROVIDED. TYPE OF INTERVENTION: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE EVENT PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644186 ↗
• MalfunctionJun 15, 2017Break; Break

  ADDITIONAL INFORMATION RECEIVED VIAL MAIL ON 22-JUNE-2017 FROM MEDWATCH #MW5070191: DEPARTMENT OF HEALTH & HUMAN SERVICES. "APPLIED KII OPTICAL 12 X 150 WAS USED AND BROKE IN HALF WHEN LENS WAS INSERTED INTO IT. BOTTOM HALF WAS RETRIEVED FROM PT'S ABDOMEN AND NO INJURY WAS NOTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6644185 ↗
• MalfunctionJun 15, 2017Break; Break

  THIS (B)(4) WILL ADDRESS THE EVENT DEVICE 1 OF 2. (B)(4) WILL ADDRESS THE EVENT DEVICE 2 OF 2. PROCEDURE PERFORMED - UNKNOWN. "I NEED TO BRING TO YOUR ATTENTION THAT DR. [DOCTOR'S NAME] HAS HAD 2 DIFFERENT CASES WHERE THE CTR71 TROCAR BROKE AND PIECES NEEDED TO BE REMOVED FROM THE PATIENT. THE LOT NUMBER FROM THE TROCAR USED IN HIS CASE TODAY IS 1288495." ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE FROM THE TERRITORY MANAGER ON (B)(6)2017: IT WAS NOTED DURING THE SURGERY THAT GAS WAS LEAKING AND UPON EXAMINING THE TROCAR, A HAIR LINE CRACK WAS OBSERVED. THE TROCAR WAS REPLACED WITH A NEW TROCAR AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE TERRITORY MANAGER ON (B)(6)2017: EVENT DEVICE WAS "THROWN AWAY" AND NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644180 ↗
• MalfunctionJun 14, 2017Break; Break

  LAPAROSCOPIC DUODENAL SWITCH - "DR.(B)(6), CHIEF OF SURGERY AT (B)(6) HOSPITAL, WAS TOWARDS THE END OF HIS LAP DUODENAL SWITCH AND USED AN INSTRUMENT (GRASPER) THROUGH A CTR71 PORT AS BHE NORMALLY WOULD AND THE BOTTOM THIRD OF THE CANNULA BROKE CLEAN OFF. THE PATIENT WAS NOT HARMED AND THE BROKEN PORTION OF THE CANNULA WAS RETRIEVED AND IS BEING SENT WITH THE TOP PORTION OF THE CANNULA. BOTH PORTIONS OF CANNULA HAVE BEEN CLEANED BY SPD AND NEED TO BE SENT IN. " TYPE OF INTERVENTION - "NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE COMPLAINT. THE BROKEN PORTION OF THE CANNULA WAS RETRIEVED" PATIENT STATUS - "NO COMPLICATIONS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641560 ↗
• MalfunctionMay 17, 2017Break; Break

  PROCEDURE PERFORMED: UNKNOWN. INCIDENT DESCRIPTION: AT THE END OF THE PROCEDURE WHEN THE USER WAS REMOVING THE TROCAR FROM THE ABDOMEN THE DOCTOR NOTICED THAT THE CANNULA CRACKED IN THE MIDDLE OF THE SHAFT. THE USER WAS ABLE TO REMOVE ALL PIECES OF THE TROCAR. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574270 ↗
• MalfunctionSep 13, 2016Break; Break

  ROBOTIC ASSISTED LAP CHOLE- "TROCAR WAS USED DURING FIRST ENTRY WITH LAPAROSCOPE. AS SURGEON WAS PLACING SECOND TROCAR HE POSITIONED THE 12X150 DOWN WITH SCOPE TO LOOK AT UPPER PORTION OF ABDOMINAL WALL TO VISUALIZE SECOND TROCAR PLACEMENT. THE 12X150 THEN SNAPPED IN HALF LEAVING A PORTION INSIDE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE AND PATIENT WAS NOT INJURED." PATIENT STATUS- "PATIENT WAS NOT INJURED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5947722 ↗
• MalfunctionAug 26, 2016Break; Leak/Splash; Break; Leak/Splash

  ROBOTIC RADICAL PROSTATECTOMY- "THE SURGERY WAS PERFORMED AND THE DOCTORS SAW THAT THE PNEUMO WAS LOST. THE DOCTORS REVIEWED THE OPTICAL TROCAR (CTR71) WAS BROKEN. THE OPTICAL TROCAR (CTR71) WAS CHANGED AND THE SAME THING HAPPENED." ADDITIONAL INFORMATION RECEIVED: THE TROCARS DID NOT PARTICULATE WHEN THEY BROKE, ONLY A CRACK AND NO PARTICULATE WAS LEFT IN THE PATIENT. PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5905500 ↗
• MalfunctionAug 24, 2016Leak/Splash; Leak/Splash

  ROBOTIC RADICAL PROSTATECTOMY: "THE SURGERY WAS PERFORMED AND THE DOCTORS SAW THAT THE PNEUMO WAS LOST. THE DOCTORS REVIEWED THE OPTICAL TROCAR (CTR71) WAS BROKEN. THE OPTICAL TROCAR (CTR71) WAS CHANGED AND THE SAME THING HAPPENED." ADDITIONAL INFORMATION RECEIVED AUGUST 09, 2016: THE LOT NUMBER WAS THE SAME FOR BOTH INCIDENTS (FIRST INCIDENT IS (B)(6)), THE TROCARS DID NOT PARTICULATE WHEN THEY BROKE, ONLY A CRACK AND NO PARTICULATE WAS LEFT IN THE PATIENT. TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "UNKNOWN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5902098 ↗