Kii Fios First Entry CTF71Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00607915125035), received between Jan 20, 2016 and Jul 10, 2025 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LSK. EVENT DESCRIPTION: ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 01JUL2025: A PIECE WAS BROKEN ON THE SLEEVE OF THE TROCAR, THIS WAS ONLY SEEN AT THE END OF THE SURGERY, THE PIECE WAS RETRIEVED IMMEDIATELY, NO NEW PRODUCT HAD TO BE USED, MANUAL DAMAGE TO THE TROCAR (BY GRASPING FORCEPS OR SIMILAR) IS NOT RULED OUT, THE PATIENT WAS NOT INJURED, THE BATCH NUMBER CAN NO LONGER BE TRACED, THE TROCAR AND THE BROKEN PIECE WERE SAVED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02JUL2025: THE TROCAR IS PACKED IN A BAG AS IT IS CONTAMINATED. IT IS A 12MM TROCAR WITH Z-THREAD, APPARENTLY THE TROCAR HAD A LENGTH OF 150MM. THE TROCAR WAS PACKED TOO TIGHTLY FOR A PHOTO, NO IMAGES AVAILABLE. IT COULD ALSO BE A CTF73. THE INCIDENT TOOK PLACE IN MID-JUNE AND THE EMPLOYEE RESPONSIBLE WAS ON VACATION FOR A WEEK AFTERWARDS. THE REPORT CAME IN ON THURSDAY THE 26TH AND I VISITED THE CUSTOMER FOR THE FIRST TIME ON (B)(6). CONCOMITANT DEVICES USED DURING THE PROCEDURE WERE OVERHOLT, SCISSORS, SALVAGE BAG GRASPING FORCEPS. THE BREAK OCCURRED AT THE TOP. THE TROCAR WAS INSERTED WITH ROTATION WITH NO DIFFIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470225 ↗
• MalfunctionNov 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: WE USED A CTF71 TROCAR AND THE TROCAR BROKE IN HALF. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 13NOV2024. NO PATIENT INJURY OR ILLNESS OCCURRED. THE PATIENT HAD O-OBP- 24-HOUR OBSERVATION. THE PROCEDURE WAS A ROBOTIC HYSTERECTOMY. OTHER DEVICES USED ALONGSIDE CTF71 WERE CTF03 AND CTF34. LOT TRACE WAS PERFORMED USING ACCOUNT ASSOCIATED WITH THE HOSPITAL (B)(6). ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 13NOV2024. THE EVENT DATE IS APRIL 27, 2017. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 18NOV2024. THE TROCAR BROKE DURING THE 2017 CASE AND IT WAS NOT REALIZED BY THE STAFF IN 2017. THE PATIENT RETURNED TO SURGERY THIS YEAR ON (B)(6), AND IT WAS DISCOVERED IN HER ABDOMEN. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 25NOV2024. THE SURGERY ON (B)(6) 2024 WAS UNRELATED TO THE TROCAR BEING LEFT INSIDE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED, O-OPB - 24 HOUR OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789182 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  PROCEDURE PERFORMED: ROBOT PARTIAL NEPHRECTOMY. EVENT DESCRIPTION: "DURING THE SETUP OF THE ROBOT, 8MM ROBOT'S TROCAR WAS INSERTED INTO OUR CTF71 TROCAR. AT THE BEGINNING OF THE PROCEDURE, THEY NOTICED THAT OUR TROCAR WAS BROKEN AND A PIECE OF IT FELL INTO THE PATIENT'S ABDOMEN. AT THE END OF THE SURGERY, THE SURGEON EXAMINED THE AREA AND GOT THE PIECE OF THE TROCAR OUT IN THE BAG WITH THE SPECIMEN." NO PATIENT INJURY. THE PATIENT WAS RELEASED HOME FEELING WELL. THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON 17APR2024: "THE TROCAR WAS INSERTED BY ROTATING IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE. THEY REPORT THERE WAS NO DIFFICULTY DURING INSERTION. THE ROBOT WAS DA VINCI SI." INTERVENTION: TOOK OUT FROM THE PATIENT ABDOMEN THE PIECE OF THE BROKEN TROCAR. PATIENT STATUS: WAS RELEASED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249872 ↗
• MalfunctionSep 28, 2021Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY EVENT DESCRIPTION: "DURING THE PROCEDURE THE CTF71 WAS BEING UTILIZED AS THE SCOPE PORT WHICH WAS PLACED IN THE UMBILICUS. DURING THE CASE I WAS TOLD THAT THEY REMOVED THE ROBOTIC SCOPE SEVERAL TIMES TO CLEAN THE LENS. AT THE END WHEN THE SURGEON REMOVED THE CTF71, HE NOTICED APPROXIMATELY 30 TO 40 PERCENT OF THE DISTAL TIP OF THE TROCAR WAS MISSING. UPON FURTHER EXAMINATION, THIS MISSING PORTION OF THE TROCAR WAS LOCATED IN THE PATIENT'S FASCIA. IT WAS SUBSEQUENTLY REMOVED AND THE CASE WAS COMPLETED. THE CTF71 WAS REMOVED, DISINFECTED AND BAGGED FOR RETURN TO APPLIED." THE TROCAR WAS NOT NOTED TO BE REPROCESSED BEFORE USE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 21SEP2021 FROM APPLIED MEDICAL REPRESENTATIVE: THE PATIENT WAS FINE AFTER THE CASE. THE BREAK OCCURRED ON THE SHAFT. THIS BREAK/FRACTURE DID NOT CAUSE ANY PARTICULATION. THE CLAMP USED WAS [NON-APPLIED MEDICAL DEVICE]. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE MISSING PORTION OF THE TROCAR WAS "SUBSEQUENTLY REMOVED AND THE CASE WAS COMPLETED." PATIENT STATUS: THE PATIENT WAS FINE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541853 ↗
• MalfunctionAug 18, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. LIMITED INFORMATION IS AVAILABLE AT THE TIME OF REPORT. WHEN REMOVING THE TROCAR AND OBTURATOR IT WAS NOTICED THAT THE TIP OF THE OBTURATOR WAS BROKEN. THE SURGEON WAS UNABLE TO LOCATE THE BROKEN PIECES OF THE OBTURATOR INSIDE THE PATIENT. THERE IS NO PATIENT INJURY TO DATE, THE PROCEDURE OCCURRED "A FEW WEEKS AGO." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6)2021 FROM ACCOUNT MANAGER I, APPLIED MEDICAL: HOSPITAL RISK MANAGEMENT HAS NOT REPLIED AFTER MULTIPLE ATTEMPTS AND URGING THE OR STAFF. THE REP WILL CONTINUE TO TRY TO GET ADDITIONAL INFORMATION ABOUT THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 20AUG2021 FROM ACCOUNT MANAGER I, APPLIED MEDICAL: THE REP HAD TRIED AGAIN AND HAD GOTTEN NO FURTHER INFORMATION PAST [THEIR] LAST UPDATE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337324 ↗
• MalfunctionApr 12, 2021Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC GASTRIC SLEEVE. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE AT THE TIME OF THE REPORT. IT WAS REPORTED THAT THE TROCAR BROKE. IT IS UNKNOWN WHERE THE BREAKAGE OCCURRED. IT IS UNKNOWN AT WHAT POINT THE BREAK WAS IDENTIFIED. IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED AFTER THE CASE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 FROM APPLIED MEDICAL ACCOUNT MGR: I WAS CONTACTED ON (B)(6) 2021. THE CASE WAS A ROBOTIC GASTRIC SLEEVE, CANNULA CRACKED NEAR THE SEAL CAP, NO PATIENT INJURY, SURGEON WAS DR. [NAME]. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 FROM APPLIED MEDICAL ACCOUNT MGR: THE TROCAR WAS USED AS A CAMERA PORT TROCAR ON AN SI INTUITIVE ROBOT. THE COUPLER WAS FOR AN APPLIED PORT. THERE WAS A CRACK IN THE TROCAR NEAR THE SEAL CAP THAT WAS NOTICED AT THE END OF THE CASE. NO NEW TROCAR WAS USED. THERE WAS NO PART OF THE TROCAR THAT ENTERED THE PATIENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648904 ↗
• MalfunctionJun 17, 2020Break; Break

  PROCEDURE PERFORMED: ROBOTIC RIGHT OVARIAN CYSTECTOMY. EVENT DESCRIPTION: THE TIP OF THE CANNULA BROKE. THE BREAK DID NOT CAUSE PARTICULATION. THE ROBOT MODEL IS UNKNOWN. THE BRAND AND SIZE OF THE CLAMP ARE UNKNOWN. THERE WAS NO PATIENT INJURY AND THE PRODUCT IS EXPECTED TO RETURN. ADDITIONAL INFORMATION WAS RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER ASSOCIATE, VIA E-MAIL ON JUNE 16, 2020: "THE SURGEON WAS USING THE SI ROBOT AND USING THE TROCAR AS THE CAMERA PORT TROCAR. IT WAS ALREADY IN THE ABDOMINAL CAVITY WITH THE CAMERA IN PLACE BUT THE SURGEON WAS STILL MANUALLY IN CONTROL OF THE CAMERA (WAS NOT YET CONTROLLING IT ROBOTICALLY). THE PATIENT WAS SMALL SO THE PORTS WERE CLOSE TOGETHER. THE LATERAL ROBOTIC PORTS WERE ALSO IN. SHE MOVED THE CAMERA IN ORDER TO VISUALIZE THE INSTRUMENT ENTERING ONE OF THE ROBOTIC PORTS. WHEN SHE MOVED THE CAMERA THE PORT CLASHED WITH THE OTHER ROBOTIC PORT AND BROKE.THE PIECES WERE RETRIEVED TO THE BEST OF THEIR KNOWLEDGE UNLESS SHARDS OF PLASTIC BROKE OFF. SURGEON EMPHASIZED SHE HAD NOT YET SWITCHED TO ROBOTIC CONTROLS IT WAS STILL MANUAL." THE BREAK WAS IDENTIFIED DURING USE. ONE PIECE WAS IN THE PATIENT, BUT "THEY BELIEVE IT WAS ALL RETRIEVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163987 ↗
• MalfunctionAug 19, 2019Break; Break

  PROCEDURE PERFORMED: ROBOTIC ASSISTED THORACOTOMY. EVENT DESCRIPTION: THE CAMERA PORT WAS REMOVED AT THE END OF THE CASE AND IT WAS NOTED THAT THE TROCAR WAS BROKE. THE TROCAR WAS REMOVED INTACT FROM THE PATIENT. IT IS UNKNOWN WHAT BRAND/MODEL CLAMP WAS USED WITH THE ROBOT. THERE WERE NO ISSUES NOTED WITH PLACEMENT OF THE PORT. NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN. THE DEVICE WILL BE RETURNED AS IS TO PREVENT FURTHER DAMAGE OF THE UNIT BEFORE EVALUATION. TYPE OF INTERVENTION: THE BROKEN TROCAR WAS REMOVED AT THE END OF THE CASE AND IT WAS NOTED THAT IT WAS BROKE. PATIENT STATUS: NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906521 ↗
• MalfunctionMar 25, 2019Break; Break

  PROCEDURE PERFORMED: DA VINCI PROSTATEKTOMIE. EVENT DESCRIPTION: INTRAOPERATIV IST DER UNTERE TEIL DER HÜLSE ABGEBROCHEN, IN DEN BAUCHRAUM GEFALLEN UND KONNTE OFFENSICHTLICH KOMPLETT GEBORGEN WERDEN. EINE BESCHÄDIGUNG DURCH EIN INSTRUMENT HAT DER KUNDE AUSGESCHLOSSEN. TRANSLATION AME: DURING THE SURGERY THE LOWER PART OF THE CANNULA BROKE OFF, FELL INTO THE ABDOMINAL CAVITY AND COULD APPARENTLY BE RETRIEVED COMPLETELY. DAMAGE DUE TO AN INSTRUMENT WAS DEEMED IMPOSSIBLE BY THE CUSTOMER. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE VIA PHONE ON 23JAN2019: THE INCIDENT OCCURRED WHILE REMOVING THE TROCAR, AT THE VERY END OF THE SURGERY. THE SURGEON NOTICED THAT THE TROCAR SEEMED TO BE STUCK, BUT COULD THEN REMOVE THE TROCAR. THAT¿S WHEN THE FRACTURE WAS NOTICED. ACCORDING TO THE CUSTOMER, THE SURGERY WAS VERY DIFFICULT BECAUSE THE PATIENT IS OBESE. THE SURGEON DID NOT HAVE ANY INDICATION THAT THE CANNULA HAD BROKEN DURING THE SURGERY; NO CRACKS, NO NOTICEABLE IMPACT OF INSTRUMENTS AGAINST THE CANNULA THIS TROCAR WAS USED AS AN ANCILLARY PORT, NOT AS A PORT FOR THE DAVINCI XI THE SALES REPRESENTATIVE WAS INFORMED ABOUT THIS INCIDENT BY PHONE, BUT WAS NOT PRESENT DURING THE S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449035 ↗
• MalfunctionJul 20, 2018Break; Break

  PROCEDURE PERFORMED: LAP GASTRIC BYPASS. EVENT DESCRIPTION: "NEAR THE END OF THE CASE THE TIP OF THE CANNULA BROKE OFF IN THE PATIENT WHEN TORQUE WAS PLACED BY THE SURGEON. ALL OF THE TROCAR WAS ABLE TO BE REMOVED FROM THE PATIENT. NO FURTHER INJURY HAPPENED TO THEIR KNOWLEDGE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM ACCOUNT MANAGER ASSOCIATE ON (B)(6) 2018: SURGEON WAS TORQUING THE TROCAR WHILE OPERATING AND IT BROKE OFF. IT WAS A NORMAL INSERTION. THIS PORT WAS AN ANCILLARY PORT DURING A "STRAIGHT STICK" NON-ROBOTIC CASE. TYPE OF INTERVENTION: "ALL OF THE TROCAR WAS ABLE TO BE REMOVED FROM THE PATIENT." PATIENT STATUS: NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7708414 ↗
• MalfunctionJun 29, 2018Fracture; Fracture

  PROCEDURE PERFORMED: "DAVINCI ASSISTED THORACOTOMY WEDGE RESECTION" EVENT DESCRIPTION: "THE PA WAS SLIDING THE INSTRUMENT THRU THE CANNULA WITH NO STRESS OR TENSION ON THE PLASTIC AND THE LOWER THIRD OF THE PLASTIC BROKE OFF IN THE PATIENTS PLEURAL CAVITY." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7653034 ↗
• MalfunctionDec 5, 2017Break; Break

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 05 DEC 2017: BARIATRIC PATIENT, WHO WAS APPROX (B)(6) KG. TROCAR IS INSERTED INTO ABDOMEN AND THE PROCEDURE STARTED. HALF WAS THROUGH THE PROCEDURE, THE SCOPE WAS TAKEN OUT TO CLEAN. WHEN SCOPE WAS INSERTED BACK INTO THE TROCAR, MISS [NAME] NOTICED THAT THE TROCAR HAS CRACKED AND TISSUE WAS COMING THROUGH. MISS [NAME] DECIDED TO CONTINUE WITH THIS TROCAR AS IT WOULD BE DIFFICULT TO INSERT ANOTHER ONE. THE CASE WAS COMPLETED WITH THE AFFECTED TROCAR. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO PATIENT WAS FINE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083019 ↗
• MalfunctionDec 1, 2017Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC. EVENT DESCRIPTION: "DR [NAME] WAS INSERTING THE TROCAR. CRACKED ON TIP OF CANNULA WHILE INSERTING. 100% SURE NOTHING WAS LEFT INSIDE THE PATIENT. NO PARTICULATION". PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7075584 ↗
• MalfunctionNov 7, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOTIC VENTRAL HERNIA REPAIR. EVENT DESCRIPTION: PART OF THE SEAL FROM INSIDE OF THE TROCAR WAS DETACHED FROM THE TROCAR AND SITTING ON TOP OF THE BOWEL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON TUESDAY 24-OCT-2017 FROM TERRITORY MANAGER: IT IS UNKNOWN IF ANY DEVICES WERE USED AT THE TIME THE INCIDENT OCCURRED. IT IS UNKNOWN OF WHAT BRAND OF CLAMP WAS USED IN THE ROBOTIC SURGERY. THE COLOR OF THE SEAL WAS BLACK. ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT AFTER FALLING IN. THE FACILITY WOULD LIKE TO REQUEST A CREDIT. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007943 ↗
• MalfunctionNov 7, 2017Break; Break

  PROCEDURE PERFORMED: RIGHT THORACOSCOPY. EVENT DESCRIPTION: IT WAS REPORTED THAT THE TROCAR WAS INSERTED AND SUCTION IRRIGATION WAS IN USE WHEN APPROXIMATELY 2 INCHES OF THE TIP OF THE CANNULA FELL DOWN INTO THE PATIENT. THE PIECE OF THE CANNULA WAS RETRIEVED AND NO ADVERSE IMPACT OCCURRED FOR THE PATIENT. THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT. TYPE OF INTERVENTION: THE PIECE OF THE CANNULA WAS RETRIEVED. PATIENT STATUS: NO ADVERSE IMPACT ON PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007166 ↗
• MalfunctionNov 7, 2017Break; Break

  PROCEDURE PERFORMED: "LAPAROSCOPIC RIGHT NEPHRECTOMY AND ADRENALECTOMY." EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. CANNULA FRACTURED. REPORT FROM THE SALES REP: DURATION OF THE SURGERY: 6 HOURS. DURING LAPAROSCOPIC RIGHT NEPHRECTOMY AND ADRENALECTOMY, AT THE END OF THE SURGERY, THE CENTER OF THE CANNULA WAS FRACTURED CAUSING THE DISTAL PART OF THE CANNULA TO REMAIN INSIDE ABDOMINAL CAVITY. THE CUSTOMER CONFIRMED THE DISTAL PART OF THE CANNULA REMAINED INSIDE ABDOMINAL CAVITY BY INSERTING THE DOCTOR'S FINGER INTO INCISION AND PUSHED IT IN THE DIRECTION FROM ABDOMINAL CAVITY TO ABDOMINAL WALL. THEN THE CUSTOMER REMOVED IT FROM PATIENT WITH A KELLY CLAMP. THE PATIENT'S BMI IS (B)(6) WITH LARGE AMOUNT OF SUBCUTANEOUS FAT AND VISCERAL FAT. THE INSERTED INSTRUMENT(SNAKE RETRACTOR) WAS USED FOR PUSHING AND HOLDING ORGAN SUCH AS KIDNEY WITH A LARGE AMOUNT OF FAT, USING EXCESSIVE FORCE UNDER THE CONDITION THAT THE RANGE OF MOTION OF TILTING THE TROCAR WAS TOO SMALL DUE TO LARGE SUBCUTANEOUS FAT THICKNESS. IT WAS LIKELY THAT THE LARGE EXCESSIVE FORCE WAS APPLIED TO THE CANNULA. THE CUSTOMER ACKNOWLEDGED THE CANNULA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007164 ↗
• MalfunctionOct 12, 2017Bent; Bent

  PROCEDURE PERFORMED: ROBOTIC HIATAL HERNIA. EVENT DESCRIPTION: "DR. [NAME] WAS PERFORMING A ROBOTIC HIATAL HERNIA. AT THE BEGINNING OF THE CASE, HE INSERTED THE CTF71 FOR HIS CAMERA PORT, THEN INSERTED THE SCOPE TO LOOK AROUND. AT THIS POINT, THERE WERE NO ISSUES. DR [NAME] REMOVED THE CAMERA FROM THE PORT AND DOCKED THE ROBOT. HE THEN ATTEMPTED TO REINSERT THE SCOPE, BUT IT WOULD NOT FULLY ADVANCE INTO THE CANNULA. HE GENTLY PUSHED THE SCOPE INTO THE TROCAR WITH NO ADVANCEMENT, AND AT THAT POINT, THE STAFF NOTICED THAT THE CANNULA WAS SLIGHTLY BENT. DR. [NAME] REMOVED THE SCOPE FROM THE CANNULA AND REMOVED THE BENT CANNULA. AT THAT POINT, THE STAFF NOTICED THAT THE LENSE OF THE SCOPE WAS CRACKLED AND HAZY, AND THAT THE SCOPE NEEDED TO BE REPLACED. DR. [NAME] INSERTED A NEW CTF71 AND USED A DIFFERENT SCOPE WITH THE NEW TROCAR. THE NEW TROCAR AND SCOPE DID NOT PRESENT ANY DIFFICULTIES." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE TERRITORY MANGER ON 12-JUNE-2017. "AS FOR THE EVENT SAMPLE, THE STAFF ASKED FOR IT TO BE SAVED AND CLEANED, BUT SPD DISCARDED IT". RECEIVED MEDWATCH FORM FROM FDA UNDER REPORT (B)(4) VIA MAIL ON 06-OCT-2017: "A 12 X 150 MM APPLIED MEDICAL ACCESS PORT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945396 ↗
• MalfunctionAug 9, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC ASSISTED RECONSTRUCTION ABDOMINAL WALL. EVENT DESCRIPTION: (B)(4) ADDRESSES EVENT 2 OF 2, (B)(4) ADDRESSES EVENT 1 OF 2. "THE SURGEON WAS PERFORMING THE PROCEDURE ON THE PATIENT. DURING RE-POSITIONING OF THE PATIENT, A NURSE NOTICED THAT THE TROCAR APPEARED TO FALL OUT OF THE PATIENT. WHEN EXAMINED CLOSER THE TROCAR BROKE IN HALF, WHILE IT WAS STILL IN THE PATIENT. THE PRODUCT WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CONTRACT COORDINATOR, ON (B)(6) 2017: LAPAROSCOPIC INSTRUMENTS WERE INSERTED INTO THE TROCAR. THE CANNULA BROKE, BUT THE BREAK WAS CLEAN. THE DA VINCI ROBOT WAS IN USE DURING THE SURGERY. IT IS NOT SURE IF THE MEDICAL CLAMP WAS IN USE WITH THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CONTRACT COORDINATOR, ON (B)(6) 2017: "THERE WERE GRASPERS AND ENERGY DEVICE INSERTED INTO THE TROCAR DURING THE PROCEDURE. THE GRASPERS ARE FROM [A COMPETITOR]. I AM UNSURE OF THE MODEL NUMBERS. I AM UNSURE OF THE ENERGY DEVICE THAT WAS IN USE WHEN THIS OCCURRED. HOWEVER, THE STAFF BELIEVES IT MAY HAVE BEEN A [COMPETITOR'S ENERGY DEVICE]." TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778893 ↗
• MalfunctionAug 8, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC ASSISTED RECONSTRUCTION ABDOMINAL WALL. EVENT DESCRIPTION: (B)(4) ADDRESSES EVENT 1 OF 2. (B)(4) ADDRESSES EVENT 2 OF 2. "THE SURGEON WAS PERFORMING THE CASE ON (B)(6) 2017, WHEN THE TROCAR BROKE IN HALF DURING THE PROCEDURE. THE PIECES OF THE PRODUCT WERE RETRIEVED AND THE PATIENT WAS NOT HARMED. UNFORTUNATELY, THERE WERE NO FURTHER DETAILS AVAILABLE AT THE TIME OF THE PROCEDURE." TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6774243 ↗
• MalfunctionJul 20, 2017Break; Break

  PROCEDURE PERFORMED: "ROBOTIC INGUINAL HERNIA REPAIR" EVENT DESCRIPTION: "WHEN DR. [NAME] WAS INSERTING HIS FIRST TROCAR, THE OUTER TROCAR CRACKED IN HALF. HE THEN ASKED FOR ANOTHER TROCAR AND THE INSERTION WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730181 ↗
• MalfunctionJul 20, 2017Break; Break

  PROCEDURE PERFORMED: "ROBOTIC INGUINAL HERNIA REPAIR". EVENT DESCRIPTION: "WHEN DR. [NAME] WAS INSERTING HIS FIRST TROCAR, THE OUTER TROCAR CRACKED IN HALF. HE THEN ASKED FOR ANOTHER TROCAR AND THE INSERTION WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730179 ↗
• MalfunctionJun 23, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: "DR [DOCTOR'S NAME] WAS USING THE TROCAR AS A ROBOTIC CAMERA PORT. HE REMOVED THE CAMERA 1/4 OF THE WAY UP THE CANNULA AND CHANGED THE ANGLE OF THE CAMERA. THE DISTAL END OF THE TROCAR MUST HAVE BEEN AGAINST ANOTHER ROBOTIC ARM/INSTRUMENT AND TORQUED THE CANNULA CAUSING IT TO CRACK.THE BROKEN PIECE DID NOT DETACH AND NO PATIENT INJURY OCCURED." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM TERRITORY MANAGER ON JUNE 15, 2017 - DAVINCI SI ROBOT WAS BEING USED WITH NO CLAMP. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED THAT WAS ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664764 ↗
• MalfunctionJun 15, 2017Break; Break

  PROCEDURE PERFORMED: LAP OOPHORECTOMY WITH LYMPH NODE REMOVAL, ROBOTIC PROCEDURE THE DOCTOR WAS TORQUING THE TROCAR VERY HARD AND THE TROCAR SNAPPED IN HALF IN A CLEAN BREAK. THE TROCAR WAS BEING USED AS A CAMERA PORT. THE PIECES WERE RETRIEVED WITH NO PATIENT INJURY. TYPE OF INTERVENTION - NA. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644199 ↗
• MalfunctionJun 15, 2017Break; Break

  ROBOTIC HYSTERECTOMY - THE TROCAR WAS BEING USED A CAMERA PORT FOR A ROBOTIC HYSTERECTOMY CASE. WHILE THE CAMERA WAS IN THE TROCAR, THE CANNULA BROKE IN HALF LEAVING THE BOTTOM END OF THE TROCAR IN THE PATIENT. THE PIECE WAS RETRIEVED. THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK. IT WAS DESCRIBED THAT THE CANNULA BROKE BELOW THE APPLIED CLAMP THAT WAS USED WITH THE DA VINCI SI ROBOT. TYPE OF INTERVENTION - NA. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644177 ↗
• MalfunctionJun 8, 2017Break; Break

  LAPAROSCOPIC TUBAL LIGATION - "THE CUSTOMER CONTACTED ME STATING THAT WHEN THE SURGEON INSERTED THE TROCAR, AND WHEN HE WENT TO REMOVE THE INSTRUMENT HE NOTICED THAT IT WOULD NOT COME OUT EASILY. WHEN HE LOOKED WITH THE CAMERA, THE BOTTOM HALF OF THE TROCAR HAD BROKEN OFF AND WAS LAYING IN THE ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE ITEM FROM THE ABDOMEN WHILE WE WERE ON THE PHONE. " ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM OR MANGER VIA EMAIL ON 02-JUNE-2017: "SURGEON FIRST NOTICED THAT PORT WAS IN 2 PIECES WHEN REMOVING SCOPE, NO ARTICULATION NOTED, 1 PIECE WAS RETRIEVED FROM ABDOMINAL CAVITY, NO OBVIOUS INJURY NOTED, PORT WAS PRIMARY UMBILICAL PORT, NO ROBOT, VARIES NEEDLE WAS USED FOR INSUFFLATION PRIOR TO PORT INSERTION" TYPE OF INTERVENTION - THE SURGEON WAS ABLE TO RETRIEVE THE ITEM FROM THE ABDOMEN. PATIENT STATUS - "NO OBVIOUS INJURY NOTED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622965 ↗