Kii Fios First Entry CTF03Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00607915123550), received between Jan 30, 2016 and Nov 21, 2025 — classified as 2 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE FIOS WAS USED WITH THE CAMERA TO MAKE THE FIRST ENTRY. UPON REMOVAL, THEY NOTICED THAT THE TIP HAD FRACTURED AND FRAGMENTED. FRAGMENTS WERE NOT RETRIEVED FROM THE PATIENT. THE HOSPITAL IS PERFORMING AN INTERNAL INVESTIGATION. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 20NOV2025: AT THE BEGINNING OF THE CASE THE PHYSICIAN WAS INSERTING WITHOUT ROTATION AND THEN HALFWAY THROUGH INSERTING TROCAR THEY STARTED ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE. THIS TROCAR WAS NOT USED WITH A ROBOT. YES THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. MEDWATCH RECEIVED FROM FDA ON 18DEC2025 VIA EMAIL: WHILE TRYING TO INSERT LAPAROSCOPIC TROCAR VIA INVISALIGN, THE END OF THE TROCAR/OBTURATOR BROKE OFF. INTERVENTION: THE TIP HAD FRAGMENTED AND PIECES WERE REPORTEDLY LEFT BEHIND IN THE PATIENT; THEY COULD NOT LOCATE IT, THEY PROCEEDED WITH THE CASE. PATIENT STATUS: FRAGMENTS WERE NOT RETRIEVED FROM THE PATIENT BUT PATIENT IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623053 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP GYNECOLOGICAL. EVENT DESCRIPTION: WHILE INTRODUCING THE PORT IS BROKE. INTERVENTION: NEW PORT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547056 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent

  SURGEON WAS INSERTING A TROCAR -OBTURATOR BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402064 ↗
• MalfunctionJun 27, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [HOSPITAL NAME] PULLED A CTF03 FOR PROCEDURE ON (B)(6) AND NOTICED THE OBTURATOR WAS BENT/BROKEN. IT WAS NOT USED ON THE PATIENT BUT DID ENTER THE STERILE FIELD. IT WAS SET ASIDE, AND A NEW ONE WAS UTILIZED FOR THE CASE. NO DANGER TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 20JUN2025: THE BEND/BREAK OCCURRED AT THE TIP. THE SHAFT BROKE PRIOR TO USING. DETECTED UPON REMOVAL FROM PACKAGING. INTERVENTION: A NEW ONE WAS UTILIZED FOR THE CASE. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346044 ↗
• MalfunctionMay 9, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY & LIVER WEDGE RESECTION. EVENT DESCRIPTION: REINSERTED INTO ABDOMEN AFTER IT HAS BEEN REMOVED AND UPON RE-ENTRY THE TIP OF THE CANNULA HAD CHIPPED OFF. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09MAY25: EVENT DATE OF 10APR25, NAME OF PROCEDURE LAPAROSCOPIC CHOLECYSTECTOMY & LIVER WEDGE RESECTION. THE TROCAR WAS INSERTED WITH MOSTLY CLOCKWISE ROTATION WITH NO DIFFICULTY DURING INSERTION. IT WAS STATED THAT THE BREAK WAS CONSIDERED A CLEAN BREAK AND UNKNOWN IF IT CAUSED PARTICULATION. LIKELY TO BE A SINGLE PIECE BROKEN OFF BUT UNABLE TO RECOVER THE PIECE HENCE, UNSURE. LIKELY A GRASPER BUT ONLY NOTICED THE BREAK AFTER IT HAPPENED. THE HEALTHCARE USER WERE UNABLE TO FIND THE BROKEN PIECE AND IT WAS AT THE END OF THE PROCEDURE, SO THEY REMOVED THE TROCAR. THE TROCAR WAS NOT USED WITH A ROBOT. INTERVENTION: IT WAS THE END OF THE PROCEDURE, SO WE REMOVED THE TROCAR. PATIENT STATUS: NO ISSUES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997004 ↗
• MalfunctionMar 19, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: THE OBTURATOR CRACKED DURING PROCEDURE AND PIECES WERE FOUND ON THE MAYO STAND. ADDITIONAL INFORMATION OBTAINED VIA PHONE CALL WITH THE ACCOUNT MANAGER ON 11MAR2025: NO PIECES FELL INTO THE PATIENT, BUT THEY CANNOT CONFIRM, NONE SPOTTED WHEN SEARCHED. THE INTERNAL SEAL COMPONENTS WERE NOT REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REP. ON 11JUN2025: THIS INCIDENT HAPPENED ON THE 6TH. THE NAME OF THE PROCEDURE WAS LAPAROSCOPIC APPENDECTOMY. INTERVENTION: USED NEW TROCAR. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647539 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  DATE OF EVENT IS UNKNOWN PROCEDURE: LAPAROSCOPIC. EVENT DESCRIPTION: THIS COMPLAINT WAS GENERATED FROM MEDSUN UF/IMPORTER REPORT #(B)(4). MODEL #: CTF03. LOT #: 1536652. DURING THE PROCEDURE, THE VIEW BECAME OBSTRUCTED AND WHEN THE CAMERA WAS REMOVED THE SURGICAL TEAM NOTED THAT THERE WERE SMALL SHARDS OF PLASTIC. ADDITIONAL INFORMATION RECEIVED FROM MEDSUN #(B)(4) REPORT VIA EMAIL ON 07MAR2025: BEGINNING LAPAROSCOPIC ENTRY INTO PATIENT ABDOMEN VIEW BECAME OBSTRUCTED AT THE MUSCLE LAYER. SURGERY TEAM REMOVED CAMERA AND NOTICED SMALL SHARDS OF PLASTIC. TEAM LEAD WAS PHONED. STAFF IN THE ROOM OBTAINED NEW [DEVICE NAME] CAMERA, NEW TROCAR AND REMOVED OLD ONES FROM THE FIELD. THE SURGERY TEAM IRRIGATED PORT SITE/WOUND THEN PROCEEDED BY CREATING NEW PORT INCISION ABOVE ORIGINAL. GAINED ENTRY INTO THE ABDOMEN, ASSESSED ORIGINAL PORT SITE AND NOTED THEY DID NOT COMPLETELY ENTER THE ABDOMEN OF THE PATIENT WHERE THE DEFECTIVE TROCAR WAS PLACED. XRAY AT END OF CASE WAS OBTAINED TO ENSURE NO FURTHER FOREIGN BODIES WERE PRESENT. NO FURTHER CLARIFICATION RECEIVED FROM USER FACILITY, THE ACCOUNT REPORTED THE SAME INCIDENT TWICE UNDER #(B)(4) DUE TO THE MATCHING INFORMATION. PATIENT STATUS: NO PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346258 ↗
• MalfunctionJan 23, 2025

  DURING THE PROCEDURE, THE VIEW BECAME OBSTRUCTED AND WHEN THE CAMERA WAS REMOVED THE SURGICAL TEAM NOTED THAT THERE WERE SMALL SHARDS OF PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217426 ↗
• MalfunctionOct 9, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN (ROBOTIC). EVENT DESCRIPTION: WE WOULD LIKE TO REPORT AN INCIDENT THE OR ON WEDS 10/2 WITH THE KII FIOS FIRST ENTRY # CTF03. DURING A CASE, THE TIP BROKE (LOT# 1492323) IN A PATIENT WHILE IN USE. ACCORDING TO THE REPORT, STAFF WERE ABLE TO RETRIEVE THE BROKEN PIECES. WE REVIEWED OUR CURRENT ON HAND INVENTORY AND FOUND NO PRODUCT WITH THE SAME LOT NUMBER. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 07OCT2024 VIA EMAIL: I WAS ABLE TO SPEAK WITH THE CNO THIS AFTERNOON AND HE STATED THAT THE INCIDENT WAS USER ERROR. A RESIDENT WAS TRYING TO INSERT THE TROCAR INTO THE ABDOMEN AND HIT THE SCOPE UPON ENTRY CAUSING THE TIP TO BREAK OFF. THE CASE WAS ROBOTIC¿ IT WAS A GENERAL CASE BUT FOLLOWING UP TO CONFIRM THE EXACT CASE. NO CONCOMITANT DEVICES WERE BEING USED. THE TROCAR WAS INSERTED IN ROTATION. THERE WAS NO DIFFICULT DURING INSERTION AND THE ROBOT WAS NOT USED DIRECTLY BUT AS AN ANCILLARY PORT. THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. INTERVENTION: STAFF WERE ABLE TO RETRIEVE THE BROKEN PIECES. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412576 ↗
• MalfunctionFeb 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DETAILED DESCRIPTION OF EVENT: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED BY EMAIL FROM FDA UNDER UF/IMPORTER REPORT (B)(4). "A HAIR WAS FOUND INSIDE THE SEALED STERILE PACKAGE." PRODUCT NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED FROM [NAME] VIA EMAIL ON 29JAN2024: "THIS COMPLAINT OCCURRED AT [FACILITY] NOT [FACILITY]." THE EVENT OCCURRED BEFORE USE. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS THE "EVENT OCCURRED OVER 90 DAYS AGO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627613 ↗
• MalfunctionJan 26, 2024

  A HAIR WAS FOUND INSIDE THE SEALED STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586539 ↗
• MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: THE TROCAR WAS INSERTED AS USUAL AND THE PNEUMOPERITONEUM WAS ESTABLISHED TO BEGIN THE PROCEDURE. DURING THE PROCEDURE INSERTING A 5MM INSTRUMENT THROUGH THE TROCAR AND THE NOTICED THE SEAL DETACHED AND THE INSTRUMENT MOVED THE SEAL FORWARD. THEY TAKE OFF THE INSTRUMENTS AND PUT AWAY THE TROCAR. TO CONTINUE THEY OPEN A NEW ONE THAT HAS NO PROBLEM. NO DAMAGES ON THE PATIENT. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 26SEP23: THE CORRECT LOT NUMBER IS 1488629. THE TM WAS NOTIFIED OF THE EVENT ON 25 SEPTEMBER 2023. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 6OCT23: A PIECE FELL INTO THE PATIENT, THE PIECE WAS RETRIEVED FROM THE PATIENT. THE PIECE WAS CLEAR. THE ENTIRE COMPONENT (SHIELD) FELL OUT. THEY WERE INSERTING A NEEDLE WHEN THE EVENT HAPPENED. 5MM GRASPER [NAME] WAS USED PRIOR TO THE INCIDENT. INTERNAL SEAL COMPONENTS WERE NO REMOVED OR CUT, THE PIECE FALLEN DOWN WAS REMOVED, THEN ANOTHER NEW TROCAR OPEN AND EVEN IF THEY INSERTED THE NEEDLE THE SEAL IN THIS CASE DIDN¿T DETACHED OR HAD ANY PROBLEMS. TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NO DAMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865327 ↗
• MalfunctionJun 6, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  PROCEDURE PERFORMED: LAP. GYN. PROCEDURE. EVENT DESCRIPTION: THE SLEEVE IS BENT DURING INSERTION. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 31MAY2023: NO PATIENT ISSUES. THE BEND/BREAK OCCURRED IN THE SHAFT. THE TROCAR WAS INSERTED ROTATED. THERE WAS NO DIFFICULTY DURING INSERTION. THE BREAK WAS NOT CONSIDERED TO BE A CLEAN BREAK. IT WAS CRACKED. THE BREAK DID NOT CAUSE PARTICULATION. THE TROCAR WAS NOT USED WITH A ROBOT. THE USER USED A NEW TROCAR. INTERVENTION: THE USER USED A NEW TROCAR. PATIENT STATUS: NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075082 ↗
• MalfunctionJun 5, 2023Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: LAPAROSCOPIC TUBAL LIGATION. EVENT DESCRIPTION: COMPLAINT CREATED BASED OFF MEDWATCH#: MW5117742. KII FIOS/Z-THREAD LEAKED AIR DUE TO A FAULTY VALVE. PT (PATIENT) UNDERGOING LAPAROSCOPIC TUBAL LIGATION. NO HARM TO THE PATIENT. PRODUCT RETURNED TO MANUFACTURER 17MAY2023. ADDITIONAL INFORMATION RECEIVED ON 02JUN2023 VIA EMAIL FROM THE USER FACILITY: THE PHYSICIAN RESOLVED THE ISSUE BY REMOVING THE TROCAR AND REPLACING WITH ANOTHER TROCAR. LAPAROSCOPIC INSTRUMENTS WERE BEING USED AT THE TIME OF THE INCIDENT. NO OTHER INSTRUMENTATION WAS USED PRIOR TO THE INCIDENT. THERE WAS NO COMPONENT DAMAGE. UNKNOWN IF THE OBTURATOR WAS INSIDE THE SEAL WHEN THE PRODUCT WAS RETURNED. ADDITIONAL INFORMATION RECEIVED ON 05JUN2023 VIA EMAIL FROM APPLIED MEDICAL ACCOUNT MANAGER: EVENT DATE IS CONFIRMED TO BE (B)(6) 2023. COMPLAINT DEVICE WAS RETURNED A FEW DAYS LATER BY CUSTOMER. TYPE OF INTERVENTION: THE PHYSICIAN RESOLVED THE ISSUE BY REMOVING THE TROCAR AND REPLACING WITH ANOTHER TROCAR. PATIENT STATUS: NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066664 ↗
• MalfunctionMar 14, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNK EVENT DESCRIPTION: LIMITED INFORMATION IS AVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 19DEC2022 FROM APPLIED MEDICAL REPRESENTATIVE: TIP OF OBTURATOR BENT GOING INTO INCISION. PRODUCT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541742 ↗
• MalfunctionMar 9, 2023Entrapment of Device; Entrapment of Device

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A 5MM ENDOSCOPE BECAME CAUGHT IN A 5MM TROCAR SLEEVE. ADDITIONAL INFORMATION RECEIVED ON 21MAR2023 VIA EMAIL FROM [USER FACILITY]: THE ITEM WAS NOT SAVED AFTER THE SURGERY. PRODUCT IS NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519279 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  PROCEDURE PERFORMED: REMOVAL OF GASTRIC BAND. EVENT DESCRIPTION: [SURGEON] WAS INSERTING THE PORT INTO THE PATIENT IN ORDER TO PUT IN A LIVER RETRACTOR. [SENIOR ODP] WAS SITTING NEXT TO THE PATIENT AND NOTICED THE OBTURATOR START TO BEND WHEN [SURGEON] WAS INSERTING IT. THE ODP NOTIFIED [SURGEON] AND WHEN [SURGEON] REMOVED THE OBTURATOR FROM THE SLEEVE HE DIDN'T SEEM TO THINK IT HAD SNAPPED. WHEN HE PASSED THE OBTURATOR TO THE ODP ON INSPECTION THE TROCAR HAD BROKEN ON ONE SIDE AND WAS STILL ATTACHED THE OTHER SIDE, SO A PARTIAL BREAK. THE ODP SAID AS SOON AS THERE WAS PRESSURE AT THE TIP OF THE OBTURATOR YOU COULD NOTICE THE DEFECT HIGHER UP IN THE SLEEVE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 14SEP2022: THE SURGEON WANTED TO MAKE AN OPENING TO INSERT A LIVER RETRACTOR IN ORDER TO DO THIS HE ONLY USES THE OBTURATOR WITHOUT THE SLEEVE SO HE ONLY HAS A SMALL FASCIAL DEFECT. THE 5MM OBTURATOR WAS INSERTED AND THE OBTURATOR BENT, WHEN IT WAS REMOVED IT WAS NOTICED THAT THE TROCAR HAD SNAPPED ON ONE SIDE. NO SLEEVES WERE USED IN CONJUNCTION WITH THE OBTURATOR SO THE INITIAL REPORT WAS INCORRECT. PATIENT STATUS: PATIENT HAD NORMAL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506158 ↗
• MalfunctionJun 30, 2022Device Slipped; Device Slipped

  PROCEDURE PERFORMED: TEP HERNIA. EVENT DESCRIPTION: [TRANSLATION]: THE TROCAR DOES NOT HOLD AND COMES OUT OF ITS ORIFICE PERMANENTLY, WHICH ENDS UP CAUSING THE PATIENT TO BLEED. THESE TROCARS ARE USED BECAUSE THERE IS A STOCK SHORTAGE ON THE TROCARS USUALLY USED IN THIS SERVICE. CURRENT CONDITION OF THE PATIENT: NEED FOR ADDITIONAL CARE FOR THE PATIENT, EVEN IF THERE WERE NO CONSEQUENCES A POSTERIORI ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: CONTROL OF BLEEDING, INTERVENTION COULD BE COMPLETED BY KEEPING THE SAME TROCAR. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE TROCAR DID NOT FIX THE ABDOMINAL WALL AND WAS ALWAYS GOING OUT. THIS PERPETUAL MOVE HAS CREATED BLEEDINGS THAT HAVE BEEN CURED DURING THE INTERVENTION. HOWEVER, THE PROCEDURE HAS BEEN COMPLETED WITH THE SAME TROCAR. PATIENT STATUS: NO CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE TROCAR HAS BEEN FIXED WITH SUTURE AND BLEEDINGS STOPPED BY HEMOSTASIS. THE PROCEDURE WAS A TEP HERNIA. THE PATIENT IS WELL. THE TROCAR HASN¿T BEEN CONSERVED (NO REASON EXPLAINED). TYPE OF INTERVENTION: CONTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881394 ↗
• MalfunctionJun 6, 2022Break; Break

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] TROKAR BROKE IN HALF IN PATIENT DURING SURGERY. IS THIS PATIENT-CRITICAL? (YES). DATE WHEN THE ERROR WAS DETECTED: (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THERE WERE NO PATIENT INJURED DURING THE SURGERY. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605384 ↗
• MalfunctionMay 9, 2022Material Fragmentation; Material Fragmentation

  EVENT 1 OF 5: (B)(6) (REPORT # 2027111-2022-00557), EVENT 2 OF 5: (B)(6) (REPORT # 2027111-2022-00558), EVENT 3 OF 5: (B)(6), EVENT 4 OF 5: (B)(6), EVENT 5 OF 5: (B)(6). PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: (B)(4), LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. NO OF INSTANCES: 2-5 ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 21AP22: I HAVE TRIED TO FOLLOW UP WITH THIS ADDITIONAL INFORMATION REGARDING THE OTHER EVENTS AND NO ONE WILL RESPOND TO ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342569 ↗
• MalfunctionMay 9, 2022Material Fragmentation; Material Fragmentation

  (B)(4). PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: CTF03, LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT (B)(6) 2024. NO OF INSTANCES: 2-5 ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: I HAVE TRIED TO FOLLOW UP WITH THIS [ADDITIONAL INFORMATION REGARDING THE OTHER EVENTS] AND NO ONE WILL RESPOND TO ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342509 ↗
• MalfunctionMay 9, 2022Material Fragmentation; Material Fragmentation

  EVENT 1 OF 5: (B)(4) (REPORT # 2027111-2022-00557). EVENT 2 OF 5: (B)(4) (REPORT # 2027111-2022-00558). EVENT 3 OF 5: (B)(4). EVENT 4 OF 5: (B)(4). EVENT 5 OF 5: (B)(4). PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU (B)(4), REF: CTF03, LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. NO OF INSTANCES: 2-5. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 21APR22: I HAVE TRIED TO FOLLOW UP WITH THIS [ADDITIONAL INFORMATION REGARDING THE OTHER EVENTS] AND NO ONE WILL RESPOND TO ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342501 ↗
• MalfunctionApr 14, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: CTF03, LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112944 ↗
• MalfunctionApr 14, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: CTF03, LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112938 ↗
• MalfunctionJan 18, 2022Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURE. EVENT DESCRIPTION: CONFIRMED DEVICE WAS INSERTED USING STANDARD DOWNWARD FORCE WITH 10-2 TWISTING MOTION. DEVICE SNAPPED WITHIN FIRST FEW SECONDS OF INSERTION (ONLY INITIAL LAYER OF SKIN PUSHED THROUGH). THE SURGEON SUBSEQUENTLY USED A REPLACEMENT PORT OF SAME PRODUCT CODE WITH NO ISSUES. PATIENT WAS ABOVE AVERAGE WEIGHT, NO PREVIOUS SURGERY. NO CHANGES IN HEALTH RESULTING FROM THE EVENT. DEVICE REPLACED WITH NO ISSUE. NO ADDITIONAL INTERVENTION REQUIRED INTERVENTION: THE SURGEON SUBSEQUENTLY USED A REPLACEMENT PORT OF SAME PRODUCT CODE WITH NO ISSUES. PATIENT STATUS: NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286069 ↗