Kii Sleeve CFS12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915119850), received between Mar 2, 2017 and Aug 18, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: OOPHORECTOMY. EVENT DESCRIPTION: ON WEDNESDAY, (B)(6) 2025, DURING SURGERY ON PATIENT [NAME], PERFORMED BY DR. [NAME], A STRUCTURAL DEFECT WAS DETECTED IN ONE OF THE 12 MM TROCARS IN THE KIT. ONE OF THE TIPS BROKE AFTER THE SURGERY BEGAN, REMAINING DANGLING FOR APPROXIMATELY 30 MINUTES BEFORE FINALLY FALLING INTO THE PATIENT'S ABDOMINAL CAVITY. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR ON 30JUL2025: THE BEND/BREAK DID NOT CAUSE PARTICULATION. IT WAS IDENTIFIED DURING USE; IT WAS INSIDE THE PATIENT'S CAVITY WHEN A PART DETACHED. THE TROCAR WAS INSERTED BY TURNING. THERE WAS NOT DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. THE OBTURATOR WAS NOT INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR ON 30JUL2025: THEY DID REMOVE THE PIECE THAT HAD FALLEN INTO THE ABDOMEN. INTERVENTION: THEY USED ANOTHER TROCAR OF THE SAME BRAND. PATIENT STATUS: PATIENT IS IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834529 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC RIGHT COLECTOMY. EVENT DESCRIPTION: [TRANSLATION] AT THE START OF THE PROCEDURE, THE SURGEON SAW A PIECE OF TROCAR IN THE PATIENT'S ABDOMEN. THE SURGEON RETRIEVED THE PIECE WITH DIFFICULTY AND ALMOST PERFORMED AN EXPLORATORY LAPAROTOMY. CUSTOMER ALSO SUBMITTED A COMPLAINT EMAIL/FORM VIA THE TM. [TRANSLATION] THE SURGEON NOTED THE PRESENCE OF A FOREIGN BODY IN THE ABDOMEN. THIS FOREIGN BODY TURNED OUT TO BE A PIECE OF TROCAR THAT HAD BECOME DETACHED. THE SURGEON REMOVED THE FOREIGN BODY, BUT HE HAD DIFFICULTY BECAUSE IT HAD MOVED INTO THE SMALL INTESTINE AND ALMOST HAD TO PERFORM AN EXPLORATORY LAPAROTOMY TO FIND THE ELEMENT. INTERVENTION: THE SURGEON RETRIEVED THE PIECE WITH DIFFICULTY AND ALMOST PERFORMED AN EXPLORATORY LAPAROTOMY. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330413 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: COELIO LAPAROSCOPIC. EVENT DESCRIPTION: REPORT WAS RECEIVED VIA NCA REF NUMBER (B)(4). [TRANSLATION] WHEN THE 10 TROCAR IS REMOVED, IT IS OBSERVED THAT THE TIP IS BROKEN. PCF FORM WAS SUBMITTED VIA TM WITH NO NEW INFO ON 15MAY25. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28MAY25: THERE WAS NO PATIENT INJURY AND PATIENT IS OK, CONCOMITANT DEVICES WINDOW CLAMP. THE TROCAR WAS INSERTED WITH ROTATION MOVEMENT WITH NO DIFFICULTY DURING INSERTION. THE BREAK DID CAUSE PARTICULATION AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE TROCAR WAS NOT USED WITH A ROBOT. INTERVENTION: SEARCH FOR INTRAPERITONEAL TROCAR END. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092461 ↗
• MalfunctionOct 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: THE APPLIED MEDICAL REPRESENTATIVE SPOKE TO THE SURGEON AND HE TOLD THEM THAT WAS HIS MISTAKE AS HE WAS PULLING OUT, THE INSTRUMENT PARTIALLY OPENED. THEY HAD TO DO THE REPORT TO THE HEALTH MINISTRY AS THEY COULD NOT FIND A SMALL PIECE OF THE TROCAR. THE PROCEDURE WAS ALREADY FINISHED WHEN THE INCIDENT OCCUR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15OCT24: IT WAS CONFIRMED IT WAS THE CANNULA THAT BROKE. THERE WAS NO PATIENT INJURY AND PATIENT IS OK. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25OCT24: THE TERRITORY MANAGER SENT OVER THE REPORT THAT WAS SUBMITTED TO NCA BY CUSTOMER. IT WAS REPORTED TO THE ITALIAN NCA WITH THE FOLLOWING : COMPLETED THE RADICAL PROSTATECTOMY SURGERY WITH EXTRACTION OF THE TROCAR IT WAS EVIDENT THAT THE PLASTIC END OF THE SAME. ONE WAS ABLE TO RECOVER A FRAGMENT OF ABOUT 3 MM BUT COULD NOT RECOVER ANOTHER ONE OF EQUAL SIZE THAT REMAINED IN THE ABDOMINAL MUSCLE TISSUE. TYPE OF INTERVENTION: PROCEDURE WAS ALREADY FINISHED WHEN THE INCIDENT OCCUR. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496504 ↗
• MalfunctionAug 29, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: RADICAL PROSTATECTOMY. EVENT DESCRIPTION: THE ISSUE BECAME EVIDENT DURING THE EXTRACTION OF THE TROCAR AT THE END OF SURGERY. AT THE END OF THE SURGERY AND THE TROCAR WAS REMOVED, IT WAS OBSERVED THAT IT WAS BROKEN, A SMALL PIECE WAS MISSING FROM THE TIP OF THE CANNULA. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON 23AUG2024: THE TROCAR WAS ROTATED IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION DURING INSERTION. THERE WAS NO DIFFICULTY DURING INSERTION. THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK. BROKEN PIECE COMPLETELY REMOVED FROM THE PATIENT. THE TROCAR WAS NOT USED WITH A ROBOT. TYPE OF INTERVENTION: THE TROCARS ARE PLACED AGAIN, THE PNEUMO IS PERFORMED, THE SURGEON LOCATES THE SMALL PIECE OF THE TROCAR AND IT IS EXTRACTED. IT IS VERIFIED THAT THE EXTRACTED PIECE FITS 100% IN THE CANNULA, CONFIRMING THAT IT IS COMPLETE. PATIENT STATUS: IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103235 ↗
• MalfunctionMay 1, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY EVENT DESCRIPTION: [TRANSLATION]THE DISTAL END OF THE SLEEVE RUPTURED INSIDE THE PATIENT! FORTUNATELY, THE SURGEON SAW THE DEFECT AND WAS ABLE TO EXTRACT THE PLASTIC TIP FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REP VIA EMAIL 24APR24: UPDATED INTERVENTION, NAME OF PROCEDURE AND CONCOMITANT DEVICE. IT WAS CLARIFIED IT WAS THE CANNULAR PART. THE TROCAR WAS INSERTED USING HANSSON TECHNIQUE VIA OPEN LAPAROSCOPIC SURGERY WITH NO DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. CAMERA WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REP VIA EMAIL 26APR24: SIX UNITS FROM THIS BATCH ARE CURRENTLY IN QUARANTINE. TYPE OF INTERVENTION: EXTRACT THE PLASTIC TIP FROM THE PATIENT PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221972 ↗
• MalfunctionFeb 24, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: TRANSLATION: ACCORDING TO MRS [NAME], NURSE AND PRESENT DURING THE INCIDENT, DURING LAPAROSCOPIC SURGERY, PLACEMENT OF A CFS12 BALLOON TROCAR SHEATH OBSERVATION DURING PLACEMENT OF THE OPTIC THAT THE EXTREMITY INTERNAL (UNDER THE BALLOON) BROKE INTO SEVERAL PIECES: A PRIORI 3. ACCORDING TO MRS [NAME], NURSE AND PRESENT DURING THE INCIDENT, LOSS OF OPERATING TIME (20 MINUTES MORE), REPOSITIONING OF ANOTHER CFS12 TROCAR FROM THE SAME BATCH AND SEARCH FOR THE 3 VISUALIZED PIECES. AFTER IDENTIFICATION THEY WERE EXTRACTED. ACCORDING TO MRS [NAME], NURSE AND PRESENT DURING THE INCIDENT, WE HAD TO LOOK FOR THESE PIECES. 3 WERE RECOVERED BY THE SURGEON. THE NURSE CHECKED, TRIED TO RECONSTRUCT THIS VERY DAMAGED AND BROKEN END, LIKE A 3D PUZZLE. THE SURGEON WATCHED THE RECONSTRUCTION. THE END APPEARED COMPLETE, ALL VISIBLE PIECES WERE RECOVERED. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 17FEB2022: ACCORDING TO DR. [NAME], PRESENT AT THE INCIDENT, THE TROCAR WAS NOT USED WITH A ROBOT. THE TROCAR WAS USED AS AN AUXILIARY TROCAR. ACCORDING TO DR. [NAME], PRESENT AT THE INCIDENT, THE TROCAR WAS USED AS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595597 ↗
• MalfunctionSep 21, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: HISTERECTOMY LAPAROSCOPY.EVENT DESCRIPTION:[TRANSLATION] DURING THE INTERVENTION, THE PART OF THE TROCAR THAT REMAINS INSIDE THE PATIENT BETWEEN THE BALLOON AND THE END OF THE OBTURATOR FRAGMENTED FALLING PIECES INTO THE ABDOMEN, ALL OF THEM WERE REMOVED WITH THE CONSEQUENTIAL RISK OF PERFORATION, INFECTION, ETC. THEY REPORT TO THE AEMPS THROUGH THE NOTIFICAPS PORTALADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 10 SEP 2021: TODAY I HAVE BEEN IN HOSPITAL [ ]. I HAVE DIFFERENTS MEETINGS WITH, [HUMAN RESOURCES], [OPERATING ROOM NURSES] AND DRA. [A], GYNECOLOGIST WHO DID THE SURGERY LAST (B)(6) 2021. THE OTHER GYN WAS DRA. [B]. DURING THE OPERATION, A LAPAROSCOPY HYSTERECTOMY, TOWARDS THE END WHEN THEY WERE CHECKING THE HEMOSTASIS THEY WHATCHED THAT THERE WAS A STRANGE PLASTIC PIECE, WHEN THEY EXTRACTED IT THEY SAW THAT IT WAS A PIECE FROM ONE OF THE TROCARS. THEY SAW THAT ONE OF THE PIECES WAS MISSING AND SEARCHED THE ABDOMEN FOR A WHILE, WHEN THEY DID NOT FIND IT THEY DECIDED THAT NEED TO DO A LAPAROTOMY TO FIND IT, THEY MADE IT AND THE MISSING PIECE APPEARED. DRA. [A] TOLD ME THAT THEY HAD WARNED UROLOGY BECAUSE THEY HAD TO CHEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508361 ↗
• MalfunctionJun 14, 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]. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: APRIL 21, 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. 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 - CFS12 LOT# 1407319 (1 EA). PATIENT STATUS: PATIENT NOT INVOLVED. TYPE OF INTERVENTION NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996132 ↗
• MalfunctionMay 10, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC RADICAL PROSTATECTOMY. EVENT DESCRIPTION: [TRANSLATION] DURING THE PROCEDURE THE DISTAL PART OF THE CANNULA HAS BROKEN AFTER A CONTACT WITH THE LAPAROCOPIC INSTRUMENT. THE PIECES OF PLASTIC IN ABDOMEN HAVE BEEN PARTIALLY RECOVERED. THE CUSTOMER WILL RETAIN THE CANNULA FOR ANY INVESTIGATION. TYPE OF INTERVENTION: THE PIECES OF PLASTIC IN ABDOMEN HAVE BEEN PARTIALLY RECOVERED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798474 ↗
• MalfunctionApr 6, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY WITH PER-OPERATOIRE CHOLANGIOGR. EVENT DESCRIPTION: [TRANSLATION] THE OPERATING WARD ENCOUNTERED A PROBLEM YESTERDAY WITH A TROCAR, CFS12 (LOT 1405882), WHEN THE SURGEON REMOVED THE TROCAR AT THE END OF THE PROCEDURE, HE REALIZED THAT IT WAS BROKEN. WE'VE RETRIEVED THE DIFFERENT PIECES. INFORMATION RECEIVED FROM CER FORM VIA EMAIL FROM USER FACILITY:[TRANSLATION] "THE INSTRUMENT NURSE THAT PREPARED THE TROCARS AT THE BEGINNING OF THE PROCEDURE INFORMED ME THAT THEY WERE IN A NORMAL STATE WHEN SHE GAVE THEM TO ME. I INSERTED THE TROCAR UNDER VISION WITHOUT ISSUES, I OPERATED WITHOUT ANYTHING OUT OF THE ORDINARY AND DID NOT USE THIS TROCAR TO EXTRACT THE GALLBLADDER OR ANYTHING ELSE BECAUSE THIS WAS THE TROCAR FOR THE SCOPE. I'VE USED A JOHAN GRASPER THROUGH TWO OPERATING TROCARS TO INSERT A DRAIN. I REMOVED THE OPTICAL TROCAR UNDER VISUAL CONTROL WITHOUT NOTICING ANYTHING. THE MOMENT WE WANTED TO CLOSE THE FASCIA OF THIS TROCAR, WE NOTICED A PIECE OF THE TROCAR IN THE SUBCUTANEOUS TISSUE." "I'VE HAD TO RETURN TO THE LAPAROSCOPY WITH TWO TROCARS AND MANIPULATE THE WHOLE OF THE ABDOMINAL CAVITY TO VERIFY THE ABSENCE OR LOSS OF THE 2ND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620175 ↗
• MalfunctionMar 1, 2019Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPY, SUSPICION OF ECTOPIC PREGNANCY. EVENT DESCRIPTION: SLEEVE BROKE BENEATH THE BALLOON DURING ENTRANCE, SURGEON DID NOT RECOGNIZE ANY RESISTANCE. THE DAMAGE WAS RECOGNIZED IMMEDIATELY. ALL PARTS OF THE BROKEN SLEEVE WERE FOUND, PATIENT IS ALRIGHT. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY PHONE ON (B)(4) 2019: THE SURGICAL TEAM WAS REFERRING TO "PARTS", SO LIKELY THIS IS A FRAGMENTED BREAK. THE PORT WAS NOT USED WITH A ROBOT. IT IS UNKNOWN WHETHER THIS WAS THE TROCAR AT THE UMBILICUS, OR AT A DIFFERENT SITE. THE METHOD OF INSERTION WAS THE FIOS TECHNIQUE. CUSTOMER REPORT FORM RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 13FEB2019: WHAT HAPPENED -> DESCRIPTION OF EVENTS IN AS MUCH DETAIL AS POSSIBLE: ON (B)(6) 2019 AT APPROXIMATELY 17:45H THE OPERATOR NOTICED DURING A LAPAROSCOPY WHILE INSERTING THE CAMERA THAT A PIECE OF PLASTIC WAS MISSING FROM THE TIP OF THE TROCAR. THE BROKEN OFF PIECE COULD BE RETRIEVED FROM THE ABDOMEN DURING THE SEARCH. THE TROCAR HAD BEEN INSERTED WITHOUT ISSUES, NO DAMAGES COULD BE IDENTIFIED. THE DEFUNCT TROCAR WAS EXCHANGED. INTERVENTION: RETRIEVAL OF BROKEN PARTS. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384042 ↗
• MalfunctionMar 16, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC NEPHRECTOMY. EVENT DESCRIPTION: THE TIP OF THE CANNULA FRACTURED AND FRAGMENTED INSIDE THE PATIENT DURING A LAP NEPHRECTOMY CASE WITH [NAME]. HE IS UNAWARE OF THE EXACT POINT IN THE PROCEDURE WHEN IT FRACTURED BUT NOTICED IT AROUND MIDWAY THROUGH, AS HE WAS MOBILIZING THE KIDNEY. THE FRAGMENT WAS RECOVERED FROM INSIDE THE PATIENT AND MATCHED THE DEFECT ON THE CANNULA, THERE WAS NO REPORTED HARM DONE TO THE PATIENT. HE NOTED THAT HE USUALLY USES THE 12X100MM ADVANCED FIXATION TROCAR HOWEVER HE USED 11X100 Z-THREAD AS THAT IS WHAT WAS GIVEN TO HIM DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED TEAM MEMBER VIA EMAIL ON (B)(6) 2018: THE SURGEON SEEMED TO THINK IT WAS A THREADED TROCAR BUT GOING BACK TO THE THEATRES TO HAVE A LOOK AT IT, I NOTICED THAT IT'S DEFINITELY A 11X100 KII SLEEVE ADVANCED FIXATION MOD.CFS12. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7347380 ↗
• MalfunctionOct 11, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "RETROPERITONEOSCOPIC LEFT ADRENALECTOMY" EVENT DESCRIPTION: "STAFF NURSE IN THE OR AT THE QUEENS SAID AN 11 MM X 100 MM HAD FRAGMENTS OF PLASTIC THAT BROKE OFF THE TIP OF THE CANNULA. THEY HAD TO RETRIEVE AT LEAST 2 PIECES AND BELIEVE THAT THEY RETRIEVED IT." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SENIOR TERRITORY MANAGER ON WEDNESDAY 20-SEP-2017 AT 12:53 AM: "THE PRODUCT ID IS KII FIOS FIXATION 11 X 100 MM, WILL TRY AND FIND PACKING TOMORROW. WILL TRY TO GET THE LOT #. INSTRUMENTS THAT WERE PASSED THRU THE TROCAR IT WAS ALSO USED AS A SCOPE PORT. THE NAME OF THE PROCEDURE IS RETRO PERITONEAL ADRENALECTOMY. THIS WAS A NON-ROBOTIC PROCEDURE. THE METHOD OF INSERTION WAS A PARTIAL CUT DOWN BETWEEN THE RIBS, PLACED ON AN ANGLE. CHANGED CANNULA, PIECES OF THE BROKEN CANNULA WAS RETRIEVED." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SENIOR TERRITORY MANAGER ON WEDNESDAY 27-SEP-2017 AT 8:49 AM: "SHE WAS INSERTING THE TROCAR AT A 30 DEGREE ANGLE BETWEEN RIBS. THE SURGEON'S NAME WAS DR. [NAME]. THE TROCAR WAS BEING USED AS A WORKING PORT, NOT A SCOPE PORT. 2 SMALL PIECES THAT WERE BROKEN OFF FROM TROCAR SLEEVE RETRIEVED AND SAVED." TYPE OF INTERVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6941170 ↗
• MalfunctionMay 31, 2017Fracture; Fracture

  PROCEDURE PERFORMED: GYNAECOLOGY. EVENT DESCRIPTION: TROCAR BROKEN, INCIDENT HAPPENED BEFORE THE DEVICE WAS USED IN SURGERY. DIFFICULTY IN OBTAINING ANY MORE DETAIL THAN THIS. ADD INFO RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON MAY 22, 2017 - "THE SEALED POUCH WAS OPENED AND TROCAR TAKEN BY SCRUB NURSE, THE YELLOW GUARD WAS NOTICED TO BE SLIGHTLY FURTHER UP THE CANNULA THAN IT NORMALLY IS, WHICH MEANT IT HAD TO BE REMOVED WITH SLIGHTLY MORE FORCE THAN USUAL. OTHER THAN THIS, NO CRACKS OR DAMAGE TO THE TROCAR HAD BEEN SEEN. IT WAS HANDED TO THE SURGEON WHO HELD IT IN ONE HAND AND THEN SHE NOTICED SOMETHING WASN'T RIGHT WITH THE TIP, THEN TOUCHED IT WITH HER OTHER HAND AND AT THIS POINT THE TIP CAME AWAY. THE DEVICE WOULD NOT HAVE COME INTO CONTACT WITH ANY SHARP INSTRUMENTS PRIOR TO THIS." PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603238 ↗
• MalfunctionMar 2, 2017Fracture; Fracture

  PROCEDURE PERFORMED UNKNOWN - "AT THE END OF THE SURGERY THEY EXAMEND THE ABDOMINAL SPACE. WHILE LOOKING UP TOWARDS THE LIVER THEY DICOVERED THAT A PLASTIC PIECE PARTLY BROKEN OFF AT THE END OF THE 11MM SLEEVE THAT WAS PLACED BELOW THE STERNUM. THEY WERE ABLE TO PULL THE PART OFF AND REMOVE IT THROUGH AN ENDOBAG. (B)(6) CAN NOT EXPLAIN HOW THIS COULD HAVE HAPPENED.THERE WAS NO SIGN OF DAMAGE BEFOR HE INSERTED THE TROKAR. DURING THE OPERATION THERE WAS NO FRICTION WHILE INSERTING THE INSTRUMENTS. ACCORDING THE OPERATING ROOM NURSE THE TROKAR WAS UNDER A LOT OF PRESSURE BECAUSE IT WAS MANEUVERED UPWARDS TO THE LIVER. AN INTRA ABDOMINAL PICTURE WILL FOLLOW A.S.A.P" PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372204 ↗