Kii® Sleeve CTS22Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00607915123734), received between Apr 8, 2016 and Sep 16, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (28 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793072 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA SURGERY WHERE A MESH NEEDED TO BE PLACED. EVENT DESCRIPTION: THE PORTHOUSE (SEAL HOUSE) BROKE WHEN A MESH WITH A GRASPER WAS PLACED THROUGH THE PORTHOUSE (SEAL HOUSE). THE BLACK AND CLEAR INSTRUMENT SEAL FALL OUT AND INTO THE PATIENTS ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 08DEC2025: TM CONFIRMED 'PORTHOUSE' MEANS SEAL HOUSE. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15DEC2025: THE PATIENT IS OK AND THE SLEEVE WAS REPLACED. BESIDES THE LAPAROSCOPIC GRASPER, NO OTHER INSTRUMENTS WAS USED AT THE TIME OF THE INCIDENT ¿ BUT A MESH WAS BEING PLACED WITH THE GRASPER. ALL PIECES RETRIEVED FROM THE PATIENT WHICH WAS BLACK AND CLEAR IN COLOUR. THE COMPONENT FELL OUT AS A WHOLE. COMPONENTS WERE INSTRUMENT SEAL BLACK AND CLEAR AND DOUBLE DUCKBILL SEAL. NO INTERNAL SEAL COMPONENTS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. INTERVENTION: THE SLEEVE WAS REPLACED. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885329 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (BEFORE USE). EVENT DESCRIPTION: WHILE OPENING THE PACKAGE, BROKEN FRAGMENTS WERE FOUND INSIDE THE STERILE POUCH. THERE IS NO IMPACT TO PATIENT. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329680 ↗
• MalfunctionJun 2, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ROUX-EN-Y. EVENT DESCRIPTION: COMPLAINT DESCRIPTION SENT TO ACCOUNT MANAGER FROM HOSPITAL REPRESENTATIVE: ONE OF THE 12MM TROCARS BROKE DURING THE CASE AND COULD OF CAUSED POTENTIAL HARM TO THE PATIENT. THE SNAP ON THE ONE SIDE OF THE TOP BROKE OFF DURING THE CASE. I UNFORTUNATELY DON'T HAVE THE ORIGINAL PACKAGING OF THIS PRODUCT BUT ALL THE LOT NUMBERS FOR THIS PRODUCT EITHER CORRELATE WITH EITHER THE 12MM WITH OBTURATOR OR JUST THE 12MM SLEEVE. THE ACCOUNT MANAGER CONFIRMS THAT ONE TROCAR MALFUNCTIONED, BUT THE HOSPITAL DOES NOT KNOW WHICH LOT NUMBER BELONGED TO THE COMPLAINT DEVICE. THE TWO TROCARS USED IN THE PROCEDURE: 1519454 AND 1541901. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE ON 16MAY2025: HOSPITAL CONTACT CONFIRMS THAT THE PIECE THAT FELL OFF WAS "THE CLIP TO THE WHITE TOP OF THE TROCAR". THE PIECE WAS RETRIEVED AND ACCOUNTED FOR. INTERVENTION: NEW TROCAR OBTAINED, PROCEDURE COMPLETED. PATIENT STATUS: PATIENT IS DOING WELL, NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127560 ↗
• MalfunctionJan 8, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR # 2027111-2025-00312). COMPLAINT 2 OF 2: (B)(4) (MFR # 2027111-2025-00311). [TRANSLATION] I HAVE JUST RECEIVED A BAG FROM THE OPERATING THEATRE OF THE VISCERAL SURGERY DEPARTMENT AND IT CONTAINS (B)(4) TROCARS INCLUDING PACKAGING. IN BOTH CASES, THE ITEM IS CTB71 WITH AN IDENTICAL LOT NUMBER (1514503) AND IN BOTH CASES THE TROCAR IS BROKEN AT THE SHAFT. IT ALL HAPPENED DURING A PATIENT, I.E. AN OPERATION, AND THE SURGEON WAS MORE THAN EXPERIENCED (HEAD PHYSICIAN OF THE DEPARTMENT WITH SENIOR PHYSICIAN AS ASSISTANT). I HAVE SENT A MAKESHIFT PHOTO AND YOU CAN ROUGHLY RECOGNISE THE FRACTURE LINES. THE (B)(6) ALSO SUBMITTED AN EMAIL SUMMARIZING THE EVENTS MENTIONED BY THE HEALTHCARE USER AFTER SHE HAD COMMUNICATION WITH THE HEALTHCARE USER. SHE DID STATE THE PATIENT WAS GOOD. ADDITIONAL INFORMATION RECEIVED VIA THE CUSTOMER VIA (B)(6) LATER ON 30DEC 2024: THE (B)(6) STATED NEW INFORMATION WAS RECEIVED, IT SEEMS THERE WERE TWO DIFFERENT TROCARS WITHIN THE SAME PROCEDURE. THE CUSTOMER STATED THE FOLLOWING: [TRANSLATION] UNFORTUNATELY, THE WHOLE EVENT WAS A BIT MORE COMPLICATED: THERE WERE TWO DIFFERENT TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105389 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC RIGHT EMICOLECTOMY + HEPATIC METASTASECTOMY. EVENT DESCRIPTION: TROCAR REGULARLY USED FOR LAPAROSCOPIC INSTRUMENTS ACCESS. AFTER 2 HOURS OF SURGERY, THE PROCEDURE REQUIRED THE INSERTION OF A TROCAR 12X100MM MORE, USING THE SAME OBTURATOR AS PREVIOUS ONE. ONCE INSERTED AND AFTER A WHILE, THE SURGEONS NOTICED THE PRESENCE OF A PLASTIC COMPONENT INTO THE ABDOMINAL CAVITY, ONCE REMOVED THEY IDENTIFIED IT AS PART OF THE TROCAR CANNULA LAST INSERTED. THIS COMPONENT IS THE TRANSPARENT ONE WHICH USUALLY STANDS ABOVE THE DOUBLE DUCK-BILL VALVE AND THE UNIVERSAL KII VALVE INSIDE THE HEAD OF THE TROCAR, LIKE THE ONE IN THE IMAGE ATTACHED. ADDITIONAL INFO RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04OCT24: CONFIRMED IT WAS WHOLE COMPONENT [CLEAR SEAL]. ADDITIONAL INFO RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10OCT24: SINCE THE COMPONENT HAS BEEN REMOVED FROM THE ABDOMINAL CAVITY AS SOON AS IT WAS NOTICED, THE PATIENT DID NOT REPORT ANY CONSEQUENCES DUE TO THE COMPLAINT EVENT. INTERVENTION: THE COMPONENT WAS REMOVED AND THE WHOLE TROCAR REPLACED. PATIENT STATUS: THE PATIENT DID NOT REPORT ANY CONSEQUENCES; NOT ANY CONSEQUEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466935 ↗
• MalfunctionOct 8, 2024Break; Fracture; Break; Fracture

  PROCEDURE PERFORMED: UNILATERAL ADRENALECTOMY IN PRONE POSITION. EVENT DESCRIPTION: COMPLAINT (B)(4) (1 OF 2), MFR REPORT NUMBER 2027111-2024-00863. COMPLAINT (B)(4) (2 OF 2), MFR REPORT NUMBER 2027111-2024-00863. THE TROCAR BROKE IN THE MIDDLE PART DURING THE OPERATION AND WAS DISCOVERED ON REMOVAL WHEN HALF OF THE TROCAR GOT STUCK IN THE PORT HOLE. IT IS UNCLEAR WHEN DURING THE OPERATION THE TROCAR BROKE. TWO DIFFERENT ARTICLE NUMBERS ARE SENT IN BY THE CUSTOMER. THE CUSTOMER WILL SEND IN 2 ART NO (CTS22 AND CTF73) LOT NO 1525327 AND LOT NO 1514216. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27SEP24: THE APPLIED MEDICAL REPRESENTATIVE HAD SPOKEN WITH THE NURSE IN CHARGE TODAY EARLIER TO CONFIRM THE FOLLOWING - BOTH DEVICES BROKE DURING THE SAME PROCEDURE ON (B)(6) 24. AWARE DATE WAS UPDATED ON 26 SEP 24 FOR BOTH COMPLAINTS. NO PATIENT INJURY AND BROKE PIECE WAS RETRIEVED AFTER SURGERY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01OCT24: NO PATIENT WAS HARMED AND NOT A ROBOTIC SURGERY. INTERVENTION: BROKE PIECE WAS RETRIEVED AFTER SURGERY. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403277 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: THORACOSCOPIC LOBECTOMY EVENT DESCRIPTION: (B)(4). THE TIP OF THE TROCAR CRACKED ON THREE SEPARATE CTS22 DEVICES IN THE SAME SURGERY. A PIECE FELL OFF INTO THE PATIENT FROM ONE OF THE TROCARS. PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER ON 20AUG2024 VIA EMAIL: THE 1458429 LOT NUMBER HAD 2 DEVICE FAILURES. 1466418 LOT NUMBER HAD 1 DEVICE FAILURE. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A FOURTH TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072398 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: THORACOSCOPIC LOBECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2024-00799), COMPLAINT 2 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2024-00800), COMPLAINT 3 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2024-00801). THE TIP OF THE TROCAR CRACKED ON THREE SEPARATE CTS22 DEVICES IN THE SAME SURGERY. A PIECE FELL OFF INTO THE PATIENT FROM ONE OF THE TROCARS. PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER ON 20AUG2024 VIA EMAIL: THE 1458429 LOT NUMBER HAD 2 DEVICE FAILURES. 1466418 LOT NUMBER HAD 1 DEVICE FAILURE. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A FOURTH TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072272 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: THORACOSCOPIC LOBECTOMY EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2024-00799); COMPLAINT 2 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2022-00705); COMPLAINT 3 OF 3: (B)(4) (MFR REPORT NUMBER 2027111-2024-00801). THE TIP OF THE TROCAR CRACKED ON THREE SEPARATE CTS22 DEVICES IN THE SAME SURGERY. A PIECE FELL OFF INTO THE PATIENT FROM ONE OF THE TROCARS. PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER ON 20AUG2024 VIA EMAIL: THE 1458429 LOT NUMBER HAD 2 DEVICE FAILURES. 1466418 LOT NUMBER HAD 1 DEVICE FAILURE. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A FOURTH TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072132 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: TARGET: ALL SUPPLIES WILL WORK AS INTENDED. ACTUAL: 12MM TROCAR WAS PLACED IN THE STERILE FASION AND WHILE THE SURGEON WAS MANIPULATING THE TROCAR IT BROKE ALONG THE SHAFT. THE EXPOSED PORTION OF THE TROCAR WAS REMOVED AND THE BROKEN PORTION OF THE TROCAR SHAFT WAS EXTRACTED FROM THE PATIENTS ABDOMINAL WALL. THE SURGEON, DR. [NAME], CHECK THE ABDOMINAL WALL FOR INJURY AND FOUND NONE. GAP: THE TROCAR SHOULD NOT HAVE BROKEN. ADDITIONAL INFORMATION PROVIDED BY [USER FACILITY] ON 30JUL2024 VIA EMAIL: EVENT OCCURRED 7/20/24. PROCEDURE BEING PERFORMED WAS LAPAROSCOPIC CHOLECYSTECTOMY. THE COLOR OF THE PIECE WAS CLEAR. [NON-APPLIED] GRASPER WAS BEING USED PRIOR AND AT THE TIME OF THE INCIDENT. NO PICTURE AVAILABLE OF THE PIECE/COMPONENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. INTERVENTION: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PATIENT STATUS: NO INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024216 ↗
• MalfunctionAug 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (DURING SERVICE). DETAILED DESCRIPTION OF EVENT: DURING THE CUSTOMER INTERNAL LABELING PROCESS, IN A CTS22 CLOSED BOX LOT NUMBER 1521725, INVOICE 9300135972, WAS DETECTED A POUCH CONTAMINATED WITH A HAIR. THE WHOLE BOX HAS BEEN SEGREGATED FOR INTEGRITY REASONS. BY CUSTOMER PROCESS, THEY ASK TO PICK UP THE WHOLE BOX WITH A CREDIT MEMO ON HAND. PATIENT STAUTS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925024 ↗
• MalfunctionApr 16, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: (B)(6). EVENT DESCRIPTION: [TRANSLATION] ON 18.1.24 WE HAD A GALL BLADDER REMOVAL BY ENDOSCOPIC SURGERY USING THE INSTRUMENT PORT KII SLEEVE REF CTS22. DURING THE CLOSING PHASE, THE SURGEON NOTICED A PIECE OF THE PORT THAT HAD COME OFF THE WOUND WITH HIS FINGER, SO THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT. THE PIECE WAS MISSING FROM THE MOUTH OF THE SURGICAL PORT SLEEVE. THE BROKEN PORT IS INTACT AND THE PACKAGES OF THE PORTS USED IN THE OPERATION ARE LOT 1496349 AND LOT 1498812. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA COMPLAINT FORM ON 29JAN24: THE OPERATION WENT WITHOUT PROBLEMS, THE PORTS WORKED WELL. DURING THE CLOSURE PHASE, THE SURGEON FELT WITH HIS FINGER A LOOSE PIECE OF PLASTIC THAT HAD COME LOOSE FROM THE GATE. THE OPERATION HAD ALREADY BEEN PERFORMED. THE SURGEON REMOVED A PIECE OF PLASTIC FROM THE WOUND. A PIECE OF PLASTIC WAS BROUGHT OUT WHOLE. THEY ALSO USED ANOTHER KII FIOS FIRST ENTRY 12 X 100MM TROCAR.(CTF73) THEY CAN'T SAY WHICH ONE TROCAR IT WAS, FROM WHERE THE PIECE OF PLASTIC HAD COME OFF. THE SECOND PORT LOT IS 1498812. TROCARS WERE SIMILAR. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115972 ↗
• MalfunctionDec 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #24045. THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: OCTOBER 6, 2023. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. ) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CTS22 LOT #1488456 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251691 ↗
• MalfunctionNov 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: BARIATRIC SURGERY. DETAILED DESCRIPTION OF EVENT: [FACILITY] ARSENALERA NOTICED THE PRESENCE OF A HAIR THE MOMENT THE TROCAR WAS PRESENTED TO HIM WHILE HE WAS ASSEMBLING HIS SURGICAL TABLE. OPEN INPUT, WITH HAIR INSIDE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24OCT2023 FROM [NAME] [DISTRIBUTOR]: NO, THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER DEVICE CTS22. PHOTOS HAVE BEEN PROVIDED. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111575 ↗
• MalfunctionJan 27, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [TRANSLATION] PLASTIC" WING" BROKE OFF AND IT WAS INSIDE THE PATIENT. BECAUSE THIS WAS NOTICED ON TIME THIS HAD NO CONSEQUENCES FOR THE PATIENT/STAFF MEMBER. NO THE COMPLAINT DID NOT LEAD TO AN UNSAFE SITUATION FOR THE PATIENT AND/OR EMPLOYEE, BUT IT COULD HAVE. PATIENT STATUS: NO CONSEQUENCES FOR THE PATIENT/STAFF MEMBER. PATIENT STATUS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254527 ↗
• MalfunctionDec 9, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  EVENT DATE IS UNKNOWN. PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] VALVE DETACHES AND FALLS INTO PATIENT'S ABDOMEN. PATIENT STATUS: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955773 ↗
• MalfunctionMay 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: COLECTOMY. EVENT DESCRIPTION: IN THE COLECTOMY THEY SAW A PIECE OF SEAL BLACK ONE IN THE ABDOMEN. THE PATIENT IS OK. THIS HAPPENED IN THE MIDDLE OF SURGERY. THEY HAVE 1 ENTIRE BOX WITH THE SAME LOT AND 8 PIECES LEFT SAME LOT, THEY TOLD ME THAT THEY WOULD LIKE TO REPLACE THE TROCAR WITH NEW ONES. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE PIECE WAS RETRIEVED FROM PATIENT. THE SEAL WAS DOUBLE DUCKBILL SEAL, THEY FOUND THE ENTIRE SEAL. THERE S NO PIC OR SEAL. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501593 ↗
• MalfunctionMay 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: CHOLECYSTECTOMY LAPAR. EVENT DESCRIPTION: IN THE CHOLECYSTECTOMY THEY SAW THE SEAL INSIDE THE ABDOMEN. IT HAPPENS AT THE BEGINNING ABOUT 15 MINUTES FROM THE START. THE PATIENT IS OK THEY TAKE OUT THE SEAL. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 22: THE SEAL WAS THE DOUBLE DUCKBILL SEAL, IT WAS ENTIRE SEAL. THERE NO PICTURE OF IT. TYPE OF INTERVENTION: THEY TAKE OUT THE SEAL. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501560 ↗
• MalfunctionMay 18, 2022Fracture; Fracture

  PROCEDURE PERFORMED: OESOPHAGUS RESECTION. EVENT DESCRIPTION: [TRANSLATION]: TODAY, DURING THE OESOPHAGUS RESECTION, WE SAW THAT OUR PORT HAD BEEN BROKEN. WE THOUGHT THIS WAS QUITE DANGEROUS. FORTUNATELY, NO PLASTIC HAD BROKEN OFF, BUT THE PLASTIC HAD BENT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: PATIENT STATUS: IS OK. THE TROCAR WAS INSERTED BETWEEN THE THORACAL BONE. THERE WAS NO DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT, LAPAROSCOPIC. INSTRUMENTS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT: [NAME] GRASPER, NEEDLE HOLDER. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432077 ↗
• MalfunctionNov 20, 2020Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS WITH SILASTIC RING. EVENT DESCRIPTION: THE PORT LEAKED THROUGH THE SEAL. THE SEAL HOUSING WAS POPPED OFF, AND WAS REPLACED WITH A NEW SEAL HOUSING TO COMPLETE THE CASE. THERE WAS NO COMPONENT SEPARATION AT THE TIME OF THE LEAKAGE. THE CASE WAS NOT ROBOTIC. A MARYLAND GRASPER WAS BEING USED AT THE TIME OF THE SEAL LEAKAGE. THE IMPLEMENTATION SPECIALIST WAS PRESENT FOR THE CASE. NO PATIENT INJURY OCCURRED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA MAUDE SEARCH ON 16NOV2020: MAUDE REPORT NUMBER (B)(4). EVENT DESCRIPTION: THE PATIENT WAS PLACED SUPINE ON THE OPERATING TABLE AND AFTER THE ADMINISTRATION OF GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED STERILELY. UTILIZING A SUPRAUMBILICAL INCISION, THE SKIN WAS SHARPLY INCISED, AND THE ABDOMEN WAS CANNULATED WITH A 12-MM NON-BLADED TROCAR. CO2 INSUFFLATION WAS UNDERTAKEN TO ACHIEVE ADEQUATE PNEUMOPERITONEUM. TEAM NOTED THAT "TROCAR HAD AIR LEAK DURING SURGERY" (PER REPORT). TROCAR WAS WITHDRAWN. ANOTHER TROCAR WAS OPENED AND INSERTED. PROCEDURE CONTINUED AND COMPLETED WITH NO FURTHER INCIDENT. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10878118 ↗
• MalfunctionMar 23, 2020Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC PLEURODESIS EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. THE SURGEON IS A NEWLY PRACTICING SURGEON. THE SURGEON PLACED THE TROCAR BETWEEN THE RIB CAGE AND DIAPHRAGM. WHILE LOOKING AROUND WITH THE SCOPE HE NOTICED A BROKEN FRAGMENT FROM THE TIP OF THE CANNULA. THE CASE WAS CONVERTED TO A OPEN PROCEDURE TO RETRIEVE THE PLASTIC PIECE IN THE PATIENT. THE PATIENT STATUS IS FINE. THE TROCAR IS AVAILABLE TO BE RETURNED. INTERVENTION: CONVERTED TO OPEN TO RETRIEVE THE PLASTIC PIECE OF THE TROCAR PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866461 ↗
• MalfunctionMar 22, 2019Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY. EVENT DESCRIPTION: THE REP, [] WAS NOT PRESENT FOR THE CASE. TROCAR BROKE AND SHARP PIECE WAS NOT RECOVERED. BREAK WAS BELOW THE SEAL WHERE IT NARROWS AND THE Z-THREADS BEGIN. CASE WAS A ROBOTIC PROSTATECTOMY WITH DR [#1] AND DR [#2]. IT WAS A DUAL PROCEDURE THAT TOOK PLACE THE EVENING OF THE 4TH. UPON COMPLETION OF THE PROSTATECTOMY PORTION, THE NURSE MOVED THE TROCAR AND NOTICED IT WAS BROKEN. THE PIECE WAS NOT RECOVERED PER THE OR MANAGER. THE OR MANAGER COMMUNICATED THAT THE DEVICE WILL BE TAKEN TO PATIENT SAFETY. REP WILL MAKE APPOINTMENT WITH DR [#1] TO GET MORE INFORMATION. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR THE PATIENT STATUS. 2 PHOTOS ARE AVAILABLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 05MAR2019 FROM ACCOUNT MANAGER ASSOCIATE: ATTACHED ARE PHOTOS OF THE EVENT DEVICE. I HAVE ALSO SPOKEN WITH DR. [#1] VIA EMAIL A FEW MOMENTS AGO. HE COMMUNICATED THAT THE PATIENT IS OKAY AND THAT TWO FRAGMENTS WERE RECOVERED. NEITHER OF THE FRAGMENTS ENTERED THE PATIENT. I¿D LIKE TO AMEND THE THE OR MANAGER¿S COMMENTS REFERRING TO THE STATUS OF THE FRAGMENTS PER DR. [#1]¿S RESPONSE. THE ITEM USED WAS CTS22 WITH A 1338836 LOT NU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444666 ↗
• MalfunctionDec 10, 2018Fracture; Fracture

  PROCEDURE PERFORMED: ROBOT ASSISTED PROSTATECTOMY. EVENT DESCRIPTION: THE DR. WANTS TO SEE THE PLACING OF THE SECOND TROCAR THROUGH THE CAMERA INSERTED IN THE FIRST TROCAR, THIS LEADS TO A VERY LIMITED SPACE AND THE TROCARS COLLIDE WITH EACH OTHER. THIS OCCURS ALMOST EVERY TIME BUT THIS IS THE FIRST TIME A TROCAR HAS BROKEN FROM IT. THE PIECE THAT BROKE OFF REMAINED ON THE TROCAR AND CAME OUT ALONG WITH IT WHEN THEY CHANGED IF FOR A NEW ONE. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 22 NOV 18: I WOULDN'T CALL IT A CLEAN BREAK. THE TIP WAS BENT INWARDS AND THE PIECE THAT BROKE OFF DIDN'T BREAK OFF IMMEDIATELY. THE BREAK WAS AT THE VERY TIP OF THE CANNULA. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 03 JAN 2019: THE SECOND TROCAR THAT WAS USED AT THE TIME OF THIS EVENT WAS DAMAGED AND RETURNED FOR EVALUATION, NOT THE FIRST TROCAR USED FOR VISUALIZATION WITH THE SCOPE. THEY BELIEVE THAT THE TROCAR WHERE THE TIP BROKE OFF HADN'T BEEN CONNECTED TO THE ROBOT YET. THE BREAKING OCCURRED DURING THE INSERTION OF THE TROCARS. THE OPTICS IS THEY ONE THE USED FOR ROBOT SURGERY, 12MM 0 DEGREES. PATIENT STATUS: NOTHING HAPPEND TO THE PATIENT AS THE PIECE OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147318 ↗
• MalfunctionNov 29, 2018Material Twisted/Bent; Material Twisted/Bent

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY CER#: (B)(4) WILL ADDRESS EVENT DEVICE 1 OF 2. CER#:(B)(4) WILL ADDRESS EVENT DEVICE 2 OF 2. EVENT DESCRIPTION: THE DOCTOR REPORTED TWO INCIDENTS OF THE SLEEVE TIP BENDING. THE DOCTOR REPORTED HAVING TROUBLE WHILE TRYING TO INTRODUCE THE TROCAR. THE TIP OF THE SLEEVE BENT. THE DOCTOR TRIED TO REPAIR THE BEND UNSUCCESSFULLY. THE SLEEVE WAS REPLACED AND THE SAME THING OCCURRED. THE DOCTOR HAS USED THE DEVICES BEFORE AND WAS NOT NEW TO THE DEVICE. THE REP WAS NOT PRESENT DURING THE CASE. THE OBTURATOR WAS INSIDE WHILE THE DOCTOR TRIED TO INTRODUCE THE TROCAR. NO INJURY OCCURRED. THE PATIENT IS 36 YEARS OLD. BOTH DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 21SEP2018 FROM REGULATORY AFFAIRS: AT THE UMBILICUS PORT I TRIED TO INTRODUCE THE TROCAR MORE THAN ONCE, WHEN I NOTICED THE TIP OF THE TROCAR WAS BEND OR IRREGULAR. I TRIED A SECOND ONE AND HAPPENED THE SAME THING. I HAD TO CUT THE APONEUROSIS WITH HASSON TECHNIQUE. THE SURGEON DID MENTIONED HE TRIED TO UNBEND THE SLEEVE WITH TWEEZERS (KELLY OR SIMILAR) IN THE OR. ADDITIONAL INSTRUMENTS USED WERE LAPAROSCOPIC INSTRUMENTS. PATIENT STATUS: HEALTHY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117446 ↗