Kii Fios First Entry CFF03Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00607915117641), received between Oct 31, 2016 and Dec 17, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: THE SURGEON WANTED TO DRAIN BILE FROM THE GALL BLADDER TO MAKE IT EASIER TO MANIPULATE DURING SURGERY. HE INSERTED AN ASPIRATION NEEDLE DOWN THE PORT WHICH THEN STARTED TO LEAK, THEREFORE, WE CHANGED IT FOR A NEW ONE. IT WASN¿T UNTIL WE WERE REMOVING THE PORTS TOWARDS THE END OF THE PROCEDURE THAT THE SURGEON NOTICED THE CLEAR PLASTIC PIECE INSIDE THE PATIENT. NO HARM OCCURRED AS IT WAS THEN REMOVED. ADDITIONAL INFORMATION AND PHOTOS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01DEC25: LOT NUMBER UPDATED ACCORDINGLY. LOT TRACE PERFORMED WITH NHS SUPPLY CHAIN ACCOUNT UNDER ID (B)(6). ADDITIONAL INFORMATION AND RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02DEC25: NO ISSUES WITH PATIENT AS A RESULT. THE USER RESOLVED THE SITUATION BY REMOVING PLASTIC PIECE DURING PROCEDURE. EVENT HAPPENED MIDWAY IN THE PROCEDURE, AS THE CONSULTANT WANTED TO DRAIN BILE FROM THE GALLBLADDER PRIOR TO REMOVAL. PIECES FELL INTO THE PATIENT AND ALL WERE RETRIEVED. ABLATION NEEDLE WAS BEING USED AT THE TIME OF THE INCIDENT. ADDITIONAL INFORMATION AND RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 03

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832762 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC HEPATECTOMY. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE HOSPITAL; THE DOUBLE DUCK BILL CAME OFF WHEN THE SEAL WAS REMOVED. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN NOT REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2025: THE DUCKBILL WAS NOT FRAGMENTED AND IT FELL ON THE SURGEON'S HAND NOT INSIDE OF THE ABDOMINAL CAVITY. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL FIELD IMPLEMENTATION PERSONNEL VIA EMAIL ON 28JAN2026: THIS COMPLAINT TURNED TO BE NPR, THE EVENT UNIT HAS BEEN DISPOSED. INTERVENTION: REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803718 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: OPERATION PERFORMED WAS A LAPAROSCOPY WITH WASHOUT FOR ANTERIOR PERFORATED DUODENUM. EVENT DESCRIPTION: X2 CFF03 WERE INSERTED IN A PARAUMBILICAL POSITION (LEFT AND RIGHT) AND AN COR47 WAS INSERTED AT THE UMBILICUS TO ACHIEVE LAPAROSCOPIC ACCESS TO THE PERITONEAL CAVITY. NURSE STATED [PRODUCT NAME] (SHARP INSTRUMENT) WAS INTRODUCED TO THE CFF03 TO ASSIST IN THE DEFLATION OF THE GALL BLADDER. WHIST DOING SO, THE [PRODUCT NAME] WAS INSERTED AT AN ANGLE AND CAUGHT THE INTERNAL, CLEAR PLASTIC DOME OF CFF03 AND WAS UNKNOWINGLY ADVANCED THROUGH THE PORT INTO THE PERITONEAL CAVITY. A CLEAR PLASTIC PIECE WAS OBSERVED IN SITU INTRAOPERATIVELY AND REMOVED BY THE ATTENDING SURGEON. THERE IS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. 15.10.2025 ADDITIONAL INFORMATION RECEIVED FROM [APPLIED MEDICAL REPRESENTATIVE] VIA EMAIL: - NAME OF THE PROCEDURE PERFORMED? - THERE IS NO ¿NAME¿ FOR THIS PROCEDURE. AS STATED ON THE FORM, ¿OPERATION PERFORMED WAS A LAPAROSCOPY WITH WASHOUT FOR? ANTERIOR PERFORATED DUODENUM¿ - CONFIRM DATE OF EVENT AS 09-FEB-2025? 10TH FEB 2025. - DID THE PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH COMPLAINT EVENT? UNKNOWN. THE HOSPITAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343580 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: REMOVAL OF AN OVARIAN CYST ¿ EXCISION OF A TERATOMA IN THE ADNEXAL REGION. EVENT DESCRIPTION: AS NORMAL. IT WAS DISCOVERED AT THE VERY END. IT IS THE PLASTIC PART ON THE INSIDE OF THE SEAL HOUSING. AT THE END OF THE OPERATION, THE SURGEON/ASSISTANT ACCIDENTALLY DISCOVERED A SMALL PIECE OF PLASTIC. THEY REMOVED IT AND EVENTUALLY IDENTIFIED ITS SOURCE. IT IS UNCERTAIN WHEN THE PLASTIC PIECE DETACHED FROM THE TROCAR. THERE HAD BEEN NO ISSUES WITH THE TROCAR DURING SURGERY ¿ THE INSTRUMENTS PASSED IN AND OUT NORMALLY, AND THERE WAS NO ABNORMAL GAS LEAKAGE. THE PIECE OF PLASTIC WAS REMOVED, AND THE OPERATION WAS COMPLETED AS NORMAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09OCT25: IMAGES ATTACHED. THE PIECE WAS CLEAR IN COLOR. THE EQUIPMENT THAT HAS BEEN USED THROUGH THE TROCARS INCLUDES: GRASPING FORCEPS, SUCTION/IRRIGATION DEVICE, DISPOSABLE PUNCTURE NEEDLE, AND THUNDERBEAT. NO INTERNAL SEAL COMPONENTS REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10OCT25: YES. THAT IS THE PLASTIC PIECE THAT IS THE REASON FOR THIS COMPLAINT. INTERVENTION: TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23338476 ↗
• MalfunctionSep 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM THE HOSPITAL. A FOREIGN MATERIAL (HAIR?) WAS CONTAMINATED IN THE STERILIZED POUCH. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY CFF03 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED TO A HOSPITAL INVENTORY. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012123 ↗
• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC OOPHORECTOMY. EVENT DESCRIPTION: AFTER INSERTING THE TROCAR AND REMOVING THE OBTURATOR, A BEND IN THE TIP OF THE OBTURATOR WAS NOTICED. DURING LAPAROSCOPIC SURGERY WITH REMOVAL OF ADNEXAL STRUCTURE, ONE OF THE TROCAR OBTURATORS WAS NOTICED TO BE BROKEN ONCE REMOVED FROM THE TROCAR AND PATIENT¿S ABDOMEN. IT WAS STILL IN ONE PIECE BUT WAS NOTICEABLY BENT/BROKE AT ABOUT 1½¿ FROM THE END OF IT. TWO CFF03 UNITS WERE UTILIZED, AND THE CLINICAL TEAM IS UNSURE WHICH SPECIFIC UNIT THE OBTURATOR WAS PACKAGED WITH. NO CLINICAL IMPACT TO THE PATIENT REPORTED OR NOTED. DEVICE DAMAGE/MALFUNCTION WAS NOTED AFTER USE OF THE OBTURATOR. THE PART WAS NO LONGER NEEDED FOR FURTHER USE IN THE PROCEDURE. SURVEILLANCE X-RAY PERFORMED NOTING NO FOREIGN BODY REMAINING IN THE PATIENT. INTERVENTION: DEVICE DAMAGE/MALFUNCTION WAS NOTED AFTER USE OF THE OBTURATOR. THE PART WAS NO LONGER NEEDED FOR FURTHER USE IN THE PROCEDURE. SURVEILLANCE X-RAY PERFORMED NOTING NO FOREIGN BODY REMAINING IN THE PATIENT. PATIENT STATUS: PATIENT HAD NO ADVERSE EFFECTS DUE TO THE MALFUNCTION/DAMAGED PRODUCT. NO CLINICAL IMPACT TO THE PATIENT REPORTED OR NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569539 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: GYN LAPAROSCOPY. EVENT DESCRIPTION: REPORTED FROM THE HOSPITAL: "WE RECENTLY HAD AN ISSUE WITH ONE OF YOUR 5 MM TROCARS' INNER VALVE COMING LOOSE AND ENDING UP INSIDE THE PATIENT. LUCKILY, WE NOTICED IT AND RETRIEVED IT." ADDITIONAL INFORMATION RECEIVED FROM HOSPITAL REPRESENTATIVE (SENT TO ACCOUNT MANAGER) VIA EMAIL ON 19MAY2025: UNFORTUNATELY, I CAN'T RECALL ALL OF THE INFORMATION YOU'RE REQUESTING. IT WAS A GYN LAPAROSCOPY CASE WITH DR. [NAME] THE PATIENT WAS FINE. WE RETRIEVED THE PLASTIC VALVE. IT WAS THE CFF03 TROCAR. I DON'T HAVE THE LOT NUMBER. THE PACKAGE WAS THROWN OUT BY THE TIME I WAS MADE AWARE OF THIS. INTERVENTION: RETRIEVED THE PLASTIC VALVE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099639 ↗
• MalfunctionJul 30, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: FOUND AT THE END OF THE SURGERY. EVENT DESCRIPTION: [TRANSLATION] THE TIP OF THE OBTURATOR BROKE OFF. DURING PORT INSERTION IN CONNECTION WITH A LAP INGV HERNIA, THE TIP OF THE OBTURATOR BROKE OFF. IT WAS USED WITH THE OPTICS FOR OPTICALLY GUIDED PORT PLACEMENT. WHEN I GOT THE OBTURATOR/SPEAR BACK, IT WAS MISSING THE TIP. THIS WAS FOUND AT THE END OF THE SURGERY IN THE PORT HOLE IN THE SUBCUTIS. INTERVENTION: LAP INGV HERNIA. PATIENT STATUS: NONE, AS THE INCIDENT WAS AVOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19867845 ↗
• MalfunctionJun 25, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPARASCOPIC DIAGNOSTIC CONVERTED TO BILATERAL SALPINGO-OOPHERECTOMY. EVENT DESCRIPTION: DURING A LAPAROSCOPIC GYNAE CASE ON MONDAY 17TH JUNE, IT WAS NOTICED AFTER THE 4TH PORT HAD BEEN PLACED, THAT THE TROCAR TIP HAD BROKEN OFF. THE PATIENT HAD HAD PREVIOUS LAPAROSCOPIC SURGERY, SO THE SURGEON THOUGHT THAT THIS WAS THE REASON SHE WAS HAVING DIFFICULTY IN PLACING THE PORT. IS THERE A RECOMMENDATION OF HOW MANY TIMES EACH TROCAR SHOULD BE USED BEFORE BEING REPLACED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PRODUCT COMPLAINT FORM ON 20JUN24: THE TROCAR WAS USED TO INSERT THE 4 PORTS USED FOR THE ABDOMINAL SURGERY. THE TIP OF THE TROCAR WAS NOTICED TO BE MISSING AFTER THE 4 PORT HAD BEEN PLACED INTO THE ABDOMEN. THE PATIENT HAD HAD PREVIOUS ABDOMINAL SURGERY AND THE SURGEON DID FIND PLACING THE PORTS NOT AS STRAIGHT FORWARD AS NORMAL. ONCE THE SURGERY WAS COMPLETED, THE SURGEON WASHED THE ABDOMEN OUT WITH SALINE BUT THE TIP OF THE TROCAR WAS NOT FOUND. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL (B)(6) 2024: UNFORTUNATELY, THE SPECIMEN WAS DISCARDED, WE HAVE ADVISED THE CUSTOMER TO RETAIN ANY AFFECTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611027 ↗
• MalfunctionNov 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  HOLD VM 11.3 NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). [DISTRIBUTOR] INCOMING INSPECTION PO (B)(6). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 1,2023 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 - CFF03 LOT #1492774 (2 EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065146 ↗
• MalfunctionAug 24, 2023Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: TROCAR BROKE IN HALF WHEN REMOVING FROM PATIENT AT END OF CASE. LOWER HALF OF TROCAR FELL INTO PATIENT AND SURGEON WAS ABLE TO RETRIEVE TROCAR FROM PATIENT. NO PATIENT INJURY OCCURRED. IT IS UNKNOWN HOW THE TROCAR WAS INSERTED. TROCAR WAS NOT USED WITH A ROBOT. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: SURGEON RETRIEVED TROCAR FROM PATIENT. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618849 ↗
• MalfunctionJan 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). [DISTRIBUTOR] INCOMING INSPECTION PO#23069. THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: DECEMBER 8,2022. 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 - CFF03 LOT #1467558 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274226 ↗
• MalfunctionJul 28, 2022Fracture; Material Fragmentation; Fracture; Material Fragmentation

  PROCEDURE PERFORMED: DIAGNOSTISCHE LSK. [TRANSLATION] TIP OF THE OBTURATOR IS BROKEN AND THE SHAFT OF THE TROCAR IS KINKED. BREAKAGE IN THE AREA OF THE KINK IN THE UPPER PART OF THE SHAFT. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123023 ↗
• MalfunctionJan 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC DRAINAGE OF CYST. EVENT DESCRIPTION: [SURGEON NAME] - ASPIRATING NEEDLE USED TO DRAIN CYST. RESISTANCE FELT BY [SURGEON NAME] WHILST ATEMPTING TO INSERT NEEDLE THROUGH TROCAR. SHE THEN TRIED TO PUSH HARDER TO OVERCOME THE RESISTANCE WHICH MEANT THAT PART OF SEAL HOUSING CAME THROUGH INTO THE ABDOMEN. THIS INFORMATION WAS TAKEN FROM [THEARTE CO-ORDINATOR NAME] WHO CLAIMED THAT THIS FAULT MAY BE FROM USER ERROR. THE BROKEN PART OF THE SEAL HOUSING WAS PULLED BACK OUT THROUGH A TROCAR AND CAUSED NO HARM TO THE PATIENT WHO WAS DISCHARGED FROM THE HOSPITAL AND HAS SUFFERED NO ILL EFFECTS. [THEARTE CO-ORDINATOR NAME] HAS COMPLETED A DATEX INCIDENT REPORT AS PART OF THEIR INTERNAL PROCEDURES. TYPE OF INTERVENTION: COMPONENT RETRIEVED. PATIENT STATUS: PATIENT IS HOME AND WELL, UNAFFECTED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386519 ↗
• MalfunctionDec 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION PO# 154P038 THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: OCTOBER 11, 2021. 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. HAIRLIKE OBJECT IN POUCH - CFF03 LOT #1422659 (1 EA). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929413 ↗
• MalfunctionOct 29, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION PO#: (B)(4). THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 3, 2021. 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. HAIRLIKE OBJECT IN POUCH - CFF03 LOT#: 1419606 (1 EA). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721084 ↗
• MalfunctionNov 9, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: DURING THE OPERATION, IT WAS NOTICED THAT A PART OF THE TROCAR WAS SMELLED, OR SCRAPED OFF. PARTICLE WAS GLUED TO THE TROCAR. PART WAS FOUND IN THE ABDOMEN OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM REGIONAL SALES MANAGER VIA PHONE ON 03-NOV-2020: ACCORDING TO THE CUSTOMER, A PLASTIC PIECE (NOT RUBBER) WAS EITHER SCRAPED OFF OR BROKEN OFF OF THE TROCAR AND FELL INTO THE PATIENT. THE CUSTOMER COULD NOT SEE WHERE THE PART HAD COME FROM, IT DID NOT SEEM TO COME FROM THE OUTSIDE OF THE TROCAR. THE PIECE WAS COLLECTED AND STUCK TO THE PACKAGING OF THE TROCAR. IT WILL BE RETURNED ALONGSIDE THE TROCAR. ADDITIONAL INFORMATION RECEIVED FROM REGIONAL SALES MANAGER VIA EMAIL ON 03-NOV-2020: THE PART ARE BY THE TROCAR. THE USER DOESN'T KNOW WHAT COLOUR THE DETACHED PART IS. THE TROCAR IS RETURNING. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813395 ↗
• MalfunctionMar 3, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  PROCEDURE PERFORMED: GASTRIC SLEEVE. EVENT DESCRIPTION: THE REP WAS PRESENT FOR THE CASE. TWO TROCARS HAD BEEN PLACED AND PNEUMO ESTABLISHED. IT WAS MENTIONED THAT THE PERITONEUM WAS TOUGH TO GET THROUGH EVEN WITH FORCE. THE PA WAS INSERTING THE THIRD TROCAR AND WAS HAVING TO TWIST A LITTLE MORE THAN USUAL WHEN THE CANNULA AND OBTURATOR BENT AT A 90 DEGREE ANGLE. THE BEND WAS ABOUT 3/4 OF THE WAY UP THE TROCAR. PULLED ANOTHER CFF03 TO USE IN THE CASE. PICTURE IS ATTACHED. THE DEVICE IS AVAILABLE FOR RETURN. INTERVENTION: OPENED ANOTHER CFF03 TO USE IN THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9782805 ↗
• MalfunctionSep 13, 2019Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC HIATAL HERNIA. EVENT DESCRIPTION: REP. WASN'T PRESENT FOR THE CASE. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. THE REP. RECEIVED AN E-MAIL FROM HIS HOSPITAL CONTACT THAT STATED THE FOLLOWING: "THE TROCAR BROKE INTO MANY PIECES INSIDE THE PATIENT YESTERDAY AFTERNOON." THE PROCEDURE BEING PERFORMED AND PATIENT STATUS IS CURRENTLY UNKNOWN AT THIS TIME. THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER, VIA E-MAIL ON SEPTEMBER 9TH, 2019: "PROCEDURE: LAPAROSCOPIC HIATAL HERNIA. PHYSICIAN: DR. [NAME]. INCIDENT DESCRIPTION: THE OBTURATOR ON THE 5 X 100 MM TROCAR BROKE WHILE IN PATIENT. ALL PIECES WERE CONFIDENTLY RECOVERED. THE PATIENT WAS NOT HARMED. THE BROKE TROCAR WAS DISPOSED OF AND IS NOT AVAILABLE TO SEND BACK TO APPLIED MEDICAL." PATIENT STATUS: "THE PATIENT WAS NOT HARMED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9037148 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC LEFT OVARIAN CYSTECYOMY. EVENT DESCRIPTION: AFTER THE SURGEON INSERTED THE BIOPSY NEEDLE THEY HEARD A LEAKING SOUND. WHILST LOOKING FOR THE SOURCE OF THE LEAK, THEY FOUND A PIECE INSIDE THE PERITONEUM. TYPE OF INTERVENTION: THE SURGEON WAS ABLE TO RETRIEVE THE PLASTIC BIT THAT CAME OFF. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341871 ↗
• MalfunctionAug 30, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: (B)(6). TIP OF OBTURATOR WAS PASSED INTO THE PATIENT AND THE TIP SHEARED OFF LEAVING THE TIP INSIDE THE PATIENTS ABDOMEN. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): RETRIEVED TIP BY MAKING A LARGER INCISION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON AUGUST 13, 2018: "I'VE SPOKEN WITH THEM AND CAN CONFIRM THERE WASN'T A PATIENT INJURY." TYPE OF INTERVENTION: RETRIEVED TIP BY MAKING A LARGER INCISION. PATIENT STATUS: THERE WASN'T A PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7835579 ↗
• MalfunctionJul 19, 2017Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPY. EVENT DESCRIPTION: "[NAME] FROM (B)(6), REPORTED TO OUR SALES SPECIALIST THAT UPON OPENING OF THE TROCAR AND SLEEVE, THE END OF THE SLEEVE WAS BROKEN AND FLATTENED." PATIENT STATUS: N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725403 ↗
• MalfunctionMar 7, 2017Fracture; Fracture

  GYN: "THE SURGEON HAD DIFFICULTIES TO ENTER THE 5MM TROCAR THE TIP OF THE OBTURATOR BENT AND ALMOST BROKE. PLEASE ORGANIZE A PICK UP WITH THE HOSPITAL." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON JULY 18, 2016 6:48 AM FROM (B)(6): AT WHAT POINT DURING THE PROCEDURE DID THE OBTURATOR TIP BREAK: THEY REALIZED THAT THE TIP WAS BROKEN AFTER THE INTRODUCTION, THEREFORE IT IS DIFFICULT TO KNOW EXACTLY AT WHAT POINT; WAS EXCESSIVE FORCE APPLIED MEDICAL USED DURING INSERTION: IT WAS A NORMAL TROCAR INTRODUCTION WITH NO EXCESSIVE PRESSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385934 ↗
• MalfunctionMar 2, 2017Physical Resistance; Physical Resistance

  ADHÄSIOLYSE (PROCEDURE TIME: 4.5 HOURS) - "THE LEADING SURGERY DR. (B)(6) USED THE TROCAR IN A TEST-OP. IN THIS PROCEDURE HE DIVIDED ADHESIONS. THE SURGEON USED THE TROCAR TO INSERT OUR SCISSOR (B)(4). DR. (B)(6) IS NOT VERY CONTENT WITH OUR SEALS OF OUR TROCARS. IF HE OPERATE A LONG TIME WITH THE TROCAR, THE SEAL WEREN´T TIGHT THE WHOLE PROCEDURE. IN THIS OPERATION HE SAID, THAT THE INSERTION OF THE SCISSOR THROUGH OUR TROCAR WASN´T VERY EASILY. THE SHEALTH OF THE SCISSOR RUB AGAINST THE SEALS. DURING THE WHOLE OPERATION THE NURSE DAMPED THE SHEALTH OF THE SCISSOR WITH OCTENISPET. OCTENISEPT IS A SOLUTION FOR WOUND DISINFECTION. THIS TWO PRODUCTS ARE STERILE SAMPLE OF ME. THE CUSTOMER DOESN´T BUY THIS PRODUCTS." PATIENT STATUS - NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372490 ↗
• MalfunctionMar 1, 2017Break; Break

  "DR. (B)(6) WAS INSERTING TROCAR INTO PATIENT AND TROCAR BROKE. INNER OBTURATOR BROKE IN HALF AND CANNULA BENT. HOSPITAL HAS TROCAR IN SEALED BAG TO SEND BACK TO APPLIED." PATIENT STATUS - NO IMPACTED BY INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370845 ↗