Kii Shielded Bladed Access System CTB73Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00607915123727), received between Apr 21, 2016 and Aug 7, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Material Deformation

  Procedure Performed:UNK.Event Description:Circumstances/Description of the incident: The trocar was deformed at the distal end (tip), which caused injury to the patient's rib upon insertion of the trocar.Clinical findings: Rib injury.Precautionary measures and actions taken: Trocar replacement.Additional information received by an Applied Medical rep via email on 28Jul2026:I didn't manage to get any information last week, I'll try again this week.Patient Status:UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183114 ↗
• MalfunctionMay 18, 2026Fracture

  PROCEDURE PERFORMED: UNK EVENT DESCRIPTION: [TRANSLATION] AFTER 1 HOUR AND 30 MINUTES OF USE DURING A PROCEDURE, THE TROCAR BROKE IN TWO (THE SHEATH CONTAINING THE OPTICAL FIBER). IT HAD NOT BEEN HEATED, NOR HAD IT BEEN STRUCK BY ANOTHER INSTRUMENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT¿S ABDOMEN USING AN EXTRACTION BAG. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207866 ↗
• MalfunctionMar 4, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPY ROBOT. EVENT DESCRIPTION: CUSTOMER SAYS THAT TROCAR BROKE IN THE PATIENT. ADDITIONAL INFORMATION REQUEST FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28FEB2025: THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE. THE DEVICE WAS USED DURING THORACOSCOPY ROBOT. NO PHOTOS AVAILABLE. TROCAR PLACEMENT EVERY THING WAS GOOD BUT WHEN SURGEON WANTS TO INTRODUCE THE CAMERA HE SAW THAT THE TROCAR WAS BROKE IN TWO PIECES. INFERIOR PART OF THE TROCAR BROKE AND THE BREAK DID NOT CAUSE PARTICULATION. THE TROCAR WAS INSERTED VIA INTERCOSTAL WITH NO DIFFICULTY INSERTION. THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516370 ↗
• MalfunctionMar 18, 2024Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: HOSPITAL: [NAME]. PRODUCT: CTB73 12X100 KII SHIELDED BLADED ACCESS SYSTEM. "BLADES FAILED TO RETRACT PROPERLY AND LOCK." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM USER FACILITY VIA EMAIL ON 27FEB2024: "THE SURGERY WAS COMPLETED WITH A NEW PRODUCT FOR SAFETY REASONS. THERE WERE NO FAULTY PRODUCTS OTHER THAN THE TROCAR. THE RED INDICATOR DID NOT REMAIN EXPOSED AFTER ACTIVATION BUT BEFORE INSERTION AND THE RED INDICATOR / BLADE REMAINED EXPOSED AFTER INSERTION." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927131 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: RIGHT LAPAROSCOPIC COLECTOMY. EVENT DESCRIPTION: [TRANSLATION]: WHEN INSERTING A LAPARO DEVICE INTO THE ADAPTED TROCAR, A PIECE OF RUBBER FROM THE MEMBRANE GOT BROKEN AND FELL (BY CHANCE IN THE OPERATOR'S FIELD OF VISION) INTO THE PATIENT'S ABDOMINAL CAVITY AND COULD HAVE BEEN UNSEEN AND LEFT IN THE ABDOMEN. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022. NAME OF PROCEDURE BEING PERFORMED: RIGHT LAPAROSCOPIC COLECTOMY. PATIENT STATUS : NOTHING TO REPORT DUE TO THE IMMEDIATE REACTION OF THE TEAM. PIECES FELL INTO THE PATIENT AND WERE ALL RETRIEVED FROM THE PATIENT. THE INNER MEMBRANE DETACHED FROM THE SEAL. THE COMPONENT WAS BLACK. THE ENTIRE COMPONENT APPEARED TO BE TORN OFF. SELF-SUTURING PLIERS DIAM 12 WERE BEING USED AT THE TIME OF THE INCIDENT. TYPE OF INTERVENTION: PIECES FELL INTO THE PATIENT AND WERE ALL RETRIEVED FROM THE PATIENT. PATIENT STATUS: NOTHING TO REPORT DUE TO THE IMMEDIATE REACTION OF THE TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14312121 ↗
• MalfunctionOct 21, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  PROCEDURE PERFORMED: LAP/OPEN LOW ANTERIOR RESECTION. EVENT DESCRIPTION: IN THE CASE, THE BLADE IN THE TROCAR COMES OUT DURING THE TROCAR INSERTION TO THE PATIENT, OR THE HEAD PART COMES OUT AT THE INSTRUMENT ENTRANCE. IN THE REPORT PREPARED BY THE HOSPITAL, [SURGEON]'S CASE OF LAP/OPEN LOW ANTERIOR RESECTION, THE TOP PLASTIC PART OF THE PRODUCT THAT WAS OPENED COULD NOT BE USED BECAUSE IT DID NOT FIT AND CAME OFF. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 20OCT21: THE PRODUCT WAS IN THE HOSPITAL AND THE HOSPITAL SENT IT TO THE DISTRIBUTOR LATE WITHOUT INFORMING THEM. DURING THE OPERATION, THE DOCTOR SAID THAT THE HEAD PART OF THE TROCAR WAS MOVING WHEN THE INSTRUMENT WAS INSERTED INTO THE TROCAR AND IT WAS DISLODGED. THE DOCTOR CONTINUED THE OPERATION AND A NEW PRODUCT WAS OPENED. THE DOCTOR COMPLETED THE SURGERY WITH THE NEW PRODUCT. THE HOSPITAL DID NOT WANT A REPLACEMENT. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: PATIENT IS SAFE POST SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674100 ↗
• MalfunctionMay 12, 2021Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. THE SURGEON ACTIVATED AND INSERTED THE TROCAR INTO THE ABDOMINAL CAVITY AT THE UMBILICUS. HE FELT THAT THE TROCAR HAD BEEN INSERTED, HE LOOKED AT THE OBTURATOR AND THE SHIELD POSITION INDICATOR WAS STILL RED. HE TOOK OUT THE OBTURATOR AND USED A SCOPE TO LOOK INTO THE ABDOMINAL CAVITY. HE SAW THAT THE SLEEVE WAS THROUGH THE CAVITY. HOWEVER HE DID NOT HEAR A SECOND CLICK AND IT "SEEMED THAT THE TROCAR BLADE WAS STILL ACTIVE." THE SURGEON IS NOT AN EXPERIENCED USER. THIS CAUSED VERY LITTLE DELAY IN THE CASE, THERE WAS NO HARM TO THE PATIENT, AND THE SAME TROCAR WAS USED TO COMPLETE THE CASE. THE REP IS UNSURE IF THERE WERE ANY OTHER INSTRUMENTS BEING USED AT THE TIME OF THE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 05MAY2021 FROM APPLIED MEDICAL TEAM MEMBER: PRIOR TO INSERTING THE TROCAR AN INSUFFLATION NEED WAS USED TO INSUFFLATE. 2 PENETRATING TOWEL CLAMPS WERE USED TO ELEVATE THE ABDOMINAL WALL FOR TROCAR. THE TROCAR WAS BEING USED FOR FIRST ENTRY. THE TROCAR WAS INSERTED WITH CONTINUOUS DOWNWARD FORCE. ADDITIONAL INFORMATION WAS RECEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814353 ↗
• MalfunctionApr 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: "LAPAROSCOPY WITH LYSIS OF ADHESIONS AND BILATERAL SALPINGO-OOPHORECTOMY" EVENT DESCRIPTION: MEDWATCH RECEIVED VIA MAIL ON 20APR2021 MW # (B)(4): "AN ELDERLY FEMALE UNDERWENT LAPAROSCOPY WITH LYSIS OF ADHESIONS, AND BILATERAL SALPINGO-OOPHORECTOMY. DURING PROCEDURE, TROCAR TOP POPPED OFF SEVERAL TIMES. THE SHAFT APPEARED TO BE THE DEFECT. NO HARM TO PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 21APR2021 FROM [USER FACILITY]: PROCEDURE WAS COMPLETED WITH "NEW TROCAR USED. DID NOT DEPLOY CORRECTLY." THE NON-CONFORMANCE WAS IDENTIFIED, "WHILE IT WAS BEING USED." THERE ARE NO PHOTOS AVAILABLE OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 22APR2021 FROM [USER FACILITY]: "THE NEW TROCAR USED TO COMPLETE CASE WORKED FINE, THE REFERENCE OF "DID NOT DEPLOY CORRECTLY" WAS IN REGARDS TO EVENT TROCAR THAT DIDN'T WORK PROPERLY." IT IS UNKNOWN IF THE NEW TROCAR WAS THE SAME MODEL AND LOT. THE NEW TROCAR WORKED APPROPRIATELY. PATIENT STATUS: "NO HARM TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732176 ↗
• MalfunctionMar 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC PROSTATECTOMY. EVENT DESCRIPTION: ON FEBRUARY THE 25TH I RECEIVED AN EMAIL FROM DR. [NAME], THE BUYER OF [HOSPITAL] IN WHICH SHE WROTE ME THAT ON(B)(6) 2020 DURING A ROBOTIC PROSTATECTOMY THE INSTRUMENTALIST SAW A PIECE OF BLACK PLASTIC IN THE PATIENT'S ABDOMEN. ONCE THE PIECE WAS EXTRACTED IT TURNED OUT TO BE ONE OF OUR TROCAR VALVES. SPECIFICALLY CTB73 LOT. 1370099. IT SEEMS THE RESULT OF AN EXCESSIVE PRESSURE APPLIED BY A NEEDLE HOLDER ON WHICH A NEEDLE WAS MOUNTED. THIS IS ALSO CLEAR FROM THE PHOTOS THAT I AM ATTACHING WHERE YOU CAN NOTICE A TEAR IN THE VALVE. IN MY OPINION, THE NEEDLE HOOKED ONTO THE VALVE AND A STRONG PUSH ON THE NEEDLE HOLDER CAUSED IT TO DETACH. THE HEAD NURSE MADE AN OFFICIAL REPORT TO THE HEALTH DEPARTMENT FOR NON-COMPLIANCE OF OUR TROCAR. THE MANAGEMENT EXPECTS OUR EXPLANATION OF WHAT MAY HAVE HAPPENED. I WILL CHECK IF THE TROCAR HAS BEEN KEPT ASIDE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823977 ↗
• MalfunctionFeb 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY EVENT DESCRIPTION: THIS MORNING ((B)(6) 2020) THE CHIEF OF THE OR TOLD ME THAT ON (B)(6) 2020 DURING A ROBOTIC PROSTATECTOMY THE NURSE SAW A PIECE OF TRANSPARENT PLASTIC IN THE PATIENT'S ABDOMEN. ONCE THE PIECE WAS EXTRACTED IT TURNED OUT TO BE ONE OF OUR TROCAR SEALS. SPECIFICALLY CTB73 LOT.1370099. AS HE HAS MOST LIKELY TOLD ME THERE HAS BEEN AN INCORRECT USE OF THE TROCAR: IT SEEMS THE RESULT OF AN EXCESSIVE PRESSURE APPLIED BY A NEEDLE HOLDER ON WHICH A NEEDLE WAS MOUNTED. SHE TOLD ME THAT MAYBE THE NEEDLE HOOKED ONTO THE VALVE AND A STRONG PUSH ON THE NEEDLE HOLDER CAUSED IT TO DETACH. THE HEAD NURSE MADE AN OFFICIAL REPORT TO THE [ITALY] HEALTH DEPARTMENT FOR NON-COMPLIANCE OF OUR TROCAR. THE MANAGEMENT EXPECTS OUR EXPLANATION OF WHAT MAY HAVE HAPPENED. UNFORTUNATELY THE TROCAR IN QUESTION HAS NOT BEEN KEPT ASIDE AND THEREFORE I CANNOT SEND IT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700608 ↗
• MalfunctionDec 20, 2019Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE AT THE TIME OF REPORTING. THE REP WAS NOT PRESENT FOR THE CASE. FOR THE 2ND TROCAR USED, THE BLADE WOULD NOT RETRACT. THEY OPENED ANOTHER TROCAR AND COMPLETED THE CASE. THE REP IS CONFIRMING IF THE DEVICE WAS USED ON THE PATIENT. IF IS UNKNOWN AT WHAT POINT IN THE PROCEDURE THE UN-RETRACTED BLADE WAS IDENTIFIED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE TROCARS ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 18DEC2019 FROM APPLIED MEDICAL HEALTH SYSTEMS SPECIALIST: "SO THE INFORMATION THAT I RECEIVED WAS FROM THE NURSE THAT WAS GIVING A BREAK. [ ] TROCAR #2 - THE BLADE DID NOT RETRACT AND THIS WAS NOTICED IMMEDIATELY UPON INSERTION. BOTH DEVICES WERE USED ON THE PATIENT (NO HARM WAS CAUSED TO THE PATIENT). [ ] A 4TH TROCAR (SAME MODEL & LOT NUMBER) WAS USED TO COMPLETE THE CASE. I WAS TOLD THAT THERE HAVE BEEN ISSUE LATELY AT THIS FACILITY WITH THIS SPECIFIC TROCAR." ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 18DEC2019 AT 3:40PM FROM APPLIED MEDICAL HEALTH SYSTEMS SPECIALIST: APPLIED MEDICAL HEALTH SYSTEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501286 ↗
• MalfunctionJul 22, 2019Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE WHEN REPORTED. RECEIVED A TROCAR THAT FAILED TO DISENGAGE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10JUL2019 FROM APPLIED MEDICAL ACCOUNT MGR: "NO PATIENT INJURY OR ILLNESS OCCURRED. SURGEON: [NAME]. ANOTHER DEVICE WAS USED WITH NO PROBLEM. ( I ASKED FOR CLARIFICATION ON THIS, BRAND, ITEM #, LOT #) THE DEVICE WAS KEPT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30JUL2019 FROM APPLIED MEDICAL ACCOUNT MGR: DATE OF THE EVENT WAS MAY 20 2019. THE PROCEDURE PERFORMED WAS A LAP AP. YES, THE TROCAR WAS USED ON THE PATIENT. THE BLADE DID NOT ENGAGE. REPORT DOES NOT STATE AT WHAT POINT IN THE PROCEDURE THE NON-CONFORMANCE WAS IDENTIFIED. ANOTHER DEVICE WAS USED. WE DO NOT DOCUMENT LOT NUMBERS. INTERVENTION: ANOTHER DEVICE WAS USED WITH NO PROBLEM. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814243 ↗
• InjuryJan 22, 2019Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL TUBAL LIGATION. EVENT DESCRIPTION: DR [] STATED THAT WHILE INSERTING THE TROCAR UNDER DIRECT VISUALIZATION, THE BLADE DID NOT RETRACT ONCE THROUGH THE ABDOMINAL TISSUE INADVERTENTLY PUNCTURING THE BOWEL. GENERAL SURGEON CALLED TO ASSIST WITH BOWEL PERFORATION. PERFORATION REPAIRED, DRAIN PLACED, PROCEDURE COMPLETED, AND PT TRANSPORTED TO PACU. PT WAS SCHEDULED AS AN OP PROCEDURE HOWEVER RESULTED IN BEING ADMITTED FOR THE BOWEL PERFORATION; PT ADMITTED TO MED SURG FLOOR AFTER PACU. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM MANAGER SURGICAL SERVICES ON TUESDAY, (B)(6) 2019: THE LOT #'S AND MODEL #'S ARE ALL THE SAME. UNFORTUNATELY WHEN THE CASE WAS FINISHING THE SURGEON PULLED ALL THE TROCARS OUT AT THE SAME TIME AND DID NOT SET ASIDE THE ONE WE HAD ISSUES WITH. I AM SENDING ALL OF THEM SINCE I DON'T KNOW WHICH ONE IT WAS BUT WE ONLY HAD ISSUES WITH 1 OF THEM. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM ACCOUNT MANAGER ON TUESDAY, (B)(6) : THE SURGEON HAS JUST BEGUN TO USE OUR SHIELD-BLADED TROCARS WITHIN THE LAST 2 MONTHS HOWEVER I DO BELIEVE HE HAS USED OUR SHEILD-BLADED TROCARS IN THE PAST, BUT TO MY KNOWLEDGE, THERE HAS

  Patient problems: Bowel Perforation

  MAUDE report 8269040 ↗
• MalfunctionNov 29, 2018Material Twisted/Bent; Material Twisted/Bent

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. CER # 2018-100565 WILL ADDRESS EVENT DEVICE 1 OF 2; CER # 2018-100566 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 TIPO 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 ST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116816 ↗
• InjuryMay 30, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "OVARIAN CYST." EVENT DESCRIPTION: "A DISTAL END(TIP) OF THE TROCAR HAS BEEN BROKEN IN THE PATIENT BODY. THE PATIENT WAS TRANSFERRED TO BIGGER HOSPITAL TO HAVE ANOTHER TREATMENT TO GET RID OF THE RESIDUE OF TROCAR. EXPENSION OF HOSPITALIZATION IS NECESSARY FOR THIS ADDITIONAL TREATMENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30MAY2018 FROM APPLIED MEDICAL TEAM MEMBER: "IT WAS A OVARIAN CASE IN [HOSPITAL NAME] HOSPITAL FOR WOMEN AT (B)(6) 2018. DR. [DOCTOR'S NAME] FOUND THE BROKEN PART OF THE CANNULA TIP IN ALL STEPS OF SURGERY, BUT, HE COULDN'T FIND WHERE THE REMAIN PART WAS. SO, THE PATIENT WAS TRANSFERRED TO A GENERAL HOSPITAL TO FIND THE TIP. FINALLY, THE BROKEN TIP WAS SEEN IN THE PATIENT'S ABDOMEN THROUGHOUT REVIEWING THE VIDEO RECORD OF SURGERY. THE PART WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. IT IS REPORTED THAT THERE HAS NOT BEEN HARM AND PROBLEM HAPPENED IN THE PATIENT SIDE WITH THIS SO FAR." PATIENT STATUS: "IT IS REPORTED THAT THERE HAS NOT BEEN HARM AND PROBLEM HAPPENED IN THE PATIENT SIDE WITH THIS SO FAR." "SAFE"

  Patient problems: Foreign Body In Patient

  MAUDE report 7555572 ↗
• MalfunctionMay 2, 2018Material Separation; Material Separation

  EVENT DESCRIPTION: MEDWATCH REPORT # (B)(4). DATE OF EVENT: (B)(6) 2018. "TROCAR BROKE DURING USE. DEVICE REPLACED AND PROCEDURE CONTINUED. NO PATIENT HARM." THE ORIGINAL INTENDED PROCEDURE IS "NO KNOWN". PATIENT INFORMATION IS "CONFIDENTIAL". PATIENT IS "NOT HISPANIC/LATINO". OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: "NO KNOWN". DEVICE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM ADMINISTRATIVE SECRETARY MATERIALS MANAGEMENT: THE DEVICE IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: "DEVICE REPLACED AND PROCEDURE CONTINUED." PATIENT STATUS: "NO PATIENT HARM"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481910 ↗
• MalfunctionOct 5, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DURING LAPAROSCOPY, IT WAS FOUND A BLACK PIECE OF PLASTIC. THIS PIECE OF PLASTIC COULD CORRESPOND TO A PART OF THE ANTI-RETURN VALVE OF THE TROCAR. THE PIECE WAS REMOVED AND THE TROCAR CHANGED. TYPE OF INTERVENTION: A SECOND DEVICE WAS USED. PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919322 ↗
• MalfunctionSep 5, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BYPASS. EVENT DESCRIPTION: DURING BYPASS AFTER INTRODUCTION OF A 5MM GRASPER, THE SURGEON OBSERVED A LEAKAGE BY THE SEAL. AS A CONSEQUENCE THE PATIENT STARTED TO LOOSE PNEUMOPERITONEUM. THE SURGEON TOOK A SECOND DEVICE AND OBSERVED THE SAME LEAKAGE PROBLEM. THE SURGEON TOOK A THIRD DEVICE AND OBSERVED THE SAME LEAKAGE PROBLEM. HE TOOK THE SEAL OF A FOURTH DEVICE AND PLACED THE SEAL ON THE THIRD DEVICE. HE ALSO OBSERVED A LEAKAGE BY THE SEAL. THE SURGEON REPORTED THAT THIS EVENT DELAYED THE PROCEDURE BY 1 AND HALF HOUR. THE SURGEON WOULD LIKE A CREDIT ON ALL UNITS. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843997 ↗
• MalfunctionSep 5, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BYPASS. EVENT DESCRIPTION: DURING BYPASS AFTER INTRODUCTION OF A 5MM GRASPER, THE SURGEON OBSERVED A LEAKAGE BY THE SEAL. AS A CONSEQUENCE THE PATIENT STARTED TO LOOSE PNEUMOPERITONEUM. THE SURGEON TOOK A SECOND DEVICE AND OBSERVED THE SAME LEAKAGE PROBLEM. THE SURGEON TOOK A THIRD DEVICE AND OBSERVED THE SAME LEAKAGE PROBLEM. HE TOOK THE SEAL OF A FOURTH DEVICE AND PLACED THE SEAL ON THE THIRD DEVICE. HE ALSO OBSERVED A LEAKAGE BY THE SEAL. THE SURGEON REPORTED THAT THIS EVENT DELAYED THE PROCEDURE BY 1 AND HALF HOUR. THE SURGEON WOULD LIKE A CREDIT ON ALL UNITS. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843038 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  "A SMALL PIECE OF PLASTIC BLACK COLOR WAS FOUND INSIDE THE PATIENT AFTER INTRODUCTION OF THE TROCART. THE PIECE OF PLASTIC HAS BEEN REMOVED SUCCESSFULLY FROM THE ABDOMEN." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372835 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP APPENDECTOMY. "DR. (B)(6) FOUND AT THE END OF THE PROCEDURE A PART OF THE SEAL (IRIS-SEAL) IN THE ABDOMEN. HE TOLD ME THAT HE WAS USING COMPRESSES / PAD ("ES-KOMPRESSEN") DURING THE PROCEDURE. IT WAS THE FIRST TIME THAT HE HAD THIS PROBLEM. HE COULD NOT TELL ME IF IT WAS A PART OF CTB73 OR CTS22; MOST LIKELY IT WAS OF THE CTB73. THE LOT OF THE CTS22 WAS 1247202. REGARDING THE RETURN : THE TROCARS WERE DISPOSED; THEY ONLY KEPT THAT PART OF THE SEAL THAT WAS FELT IN THE ABDOMEN AND WHICH WAS RETRIEVED." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372196 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  "WHILE USING THE SUTURE CLOSING DEVICE A PIECE OF THE SEAL CAME OFF FROM THE TROCAR. SUTURE DEVICE INCLUDED WITH TROCAR. PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370834 ↗
• MalfunctionFeb 8, 2017Break; Break

  SLEEVE SURGERY - TROCAR BROKEN IN 2 INSIDE THE ABDOMEN. (DURING A SLEEVE, THE SURGEON OBSERVED THIS AT THE END OF THE SURGERY) THERE WAS NO IMMEDIATE POST OPERATION COMPLICATIONS. ORIGINAL: TROCARD CASSÉ EN 2 DANS LA PAROI ABDOMINALE. (LORS D'UNE SLEEVE, LE CHIRURGIEN S'EN EST RENDU COMPTE EN FIN D'INTERVENTION) PAS DE COMPLICATIONS POST OPÉRATOIRES IMMÉDIATES. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 13 JANUARY 2017: THE FRACTURE OCCURRED ON THE SLEEVE. AT THE END OF THE INTERVENTION (SLEEVE SURGERY), WHEN THE SURGEON REMOVED THE TROCAR, HE REALISED THAT A PART OF THE TROCAR WAS MISSING : THE SECOND PART WAS IN THE ABDOMINAL WALL... IT WAS A CLEAN BREAK, ALL PIECES HAVE BEEN RETRIEVED FROM THE ABDOMEN. THE PORT WAS AN ANCILLARY PORT. THE METHOD OF INSERTION WAS CLASSIC BUT THE PATIENT WAS REALLY FAT: (B)(6). PATIENT STATUS - NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312051 ↗
• MalfunctionNov 16, 2016Break; Material Fragmentation; Break; Material Fragmentation

  LAP APPENDICECTOMY - "WHEN RETRIEVING THE SPECIMEN THE BERT BAG GOT JAMMED IN THE CANNULA. IT WAS THEN PUSHED BACK IN TO THE PATIENT AT WHICH POINT THE SEAL COMPONENTS FELL INTO THE PATIENT. THE SURGEONS WERE CONCERNED THAT SOME OF THE COMPONENTS COULD HAVE BEEN LEFT UNIDENTIFIED INSIDE THE PATIENT AND WOULD LIKE ENGINEERING TO CONFIRM ALL THE COMPONENTS TO BE SENT BACK MAKE UP THE FULL CANNULA, AND THEREFORE THAT NOTHING HAS BEEN LEFT INSIDE THE PATIENT. ONE OF THE PINCH TABS HAD ALSO BROKEN OFF." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2016: THE SURGEON AND NURSE SAID THAT THE PATIENT WAS FINE BUT THEY WERE JUST WORRIED THAT SOMETHING HAD BEEN LEFT INSIDE AND SO WERE QUERYING DOING AN ULTRASOUND SCAN... PATIENT STATUS: "FINE"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106560 ↗
• MalfunctionApr 21, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED UNKNOWN - "THE UPPER PART OF THE DEVICE (WHITE) GOT DISASSEMBLED FROM ITS SUPPORT WITHOUT ANY POSSIBILITY TO SET IT BACK IN PLAC. LOSS OF PNEUMOPERITONEUM. TROCAR UNUSABLE." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5596363 ↗