Kii® OPTICAL ACCESS SYSTEM CTR73Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00607915123680), received between Feb 3, 2016 and Aug 31, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (53 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Procedure Performed: Laparoscopic Appendectomy. Event Description: (b)(4) Operating room submitting a product problem log. On (b)(6), during a laparoscopic case, Access system Ref#(b)(4) trocar came apart during use. The clear circular piece was retrieved without incident. Picture attached and product saved. Surgeon, Dr. "[Name]", would like to be contacted by rep. Risk management would also like a follow up. Additional information provided by Applied Medical representative via email on 13AUG2026: Thank you very much for letting me know. I was actually on site yesterday speaking with Dr. "[Name]", however I was unaware that Dr. "[Name]" experienced an issue. I am glad to hear that the patient is doing well. I will find out when he is on the schedule next and make sure to come in and speak with him. Thank you for making me aware. If you could, please put me in touch with the risk management team, I will absolutely reach out to them as well. Thank you for your time. Additional information provided by Nurse from the facility via email on 17AUG2026: The piece fell into the abdomen and was successfully retrieved from the patient. No instrumentation passed through the event unit during t

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524769 ↗
• MalfunctionJul 27, 2026Fracture

  Procedure Performed: Robotic-assisted Esophagectomy. Event Description: During the surgery, the Trocar 12mm port broke into right pleural cavity into what the team felt was 4 pieces/shards. 3 pieces/shards were located with 1 potential shard left in the patient likely causing no harm. Imaging completed with no location of a remaining shard. Device failed (e.g. broke, couldn't get it to work or stopped working). Patient Status: No patient injury indicated. The date of the event is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009485 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC LIVER RESECTION. EVENT DESCRIPTION: THE ENTIRE OF DUCKBILL FELL INTO THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED WITH A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524822 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC HERNIORRHAPHY. EVENT DESCRIPTION: THIS MORNING WE HAVE HAD ANOTHER 12MM TROCAR ISSUE WITH THE TAB ON THE SIDE BREAKING OFF WHEN [SURGEON] WAS ATTEMPTING TO REMOVE THE WHITE CAP. NO HARM OCCURRED TO THE PATIENT AND THE BROKEN PIECE WAS RETRIEVED. I HAVE THE TROCAR AND THE PACKAGING AND I ASSUME WHEN [HEALTHCARE WORKER] GETS BACK NEXT WEEK SHE WILL TAKE A LOOK AND THEN LET YOU HAVE IT, [APPLIED REPRESENTATIVE], BUT NOT MY DECISION TO MAKE OF COURSE. I RECEIVED THIS EMAIL THIS MORNING THAT SAID A GENERAL SURGEON DR. [NAME] AT [HOSPITAL] HAD AN ISSUE WITH A 12MM APPLIED MEDICAL TROCAR. ONE OF THE TABS BROKE OFF WHEN THE SURGEON TRIED REMOVING THE SEAL CAP FROM THE TROCAR. THE INSTRUMENT WAS SAVED, AND THEY WILL NEED TO DO THEIR OWN INVESTIGATION BEFORE ALLOWING THE TROCAR TO BE RELEASED TO APPLIED MEDICAL. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 05DEC2025: I WAS NOT ABLE TO SPEAK WITH THE SURGEON BUT WAS TOLD HE SAID HE PINCHED THE TABS TO REMOVE THE SEALING HOUSE, AND THE ONE SIDE BROKE. THE TAB DID NOT FALL INTO THE TROCAR. THE SURGEON DID NOT HAVE PINCH ANY HARDER THAN HE NORMALLY WOULD. EVENT HAPPENED AT THE END OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850687 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPROSCOPIC SUTURE GASTRORRHAPHY WITH OMENTUM PATCH. EVENT DESCRIPTION: YES, DR. [NAME] DID HAVE AN ISSUE WITH A TROCAR. ON SATURDAY, (B)(6) DR. [NAME] WAS FINISHING UP A LAPROSCOPIC SUTURE GASTRORRHAPHY WITH OMENTUM PATCH, AND WHEN HE DEPRESSED THE CLEAR TABS ON EACH SIDE OF THE 12MM CTR73 TROCAR TO DE-INSUFFLATE THE ABDOMEN, ONE OF THE TWO CLEAR TABS ON THE SIDE OF THE TROCAR BROKE OFF AT THE POINT AFTER THE REINFORCEMENT ATTACHES (AT THE CURVE WHERE THE TAB GOES PARALLEL TO THE TROCAR) AND THE BROKEN PIECE WENT INTO THE OPENING OF THE TROCAR AND INTO THE PATIENT. HE FOUND THE BROKEN-OFF PIECE IN THE ABDOMEN WITHOUT DIFFICULTY AND REMOVED IT. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT THAT WE KNOW OF THEN OR THUS FAR. WE HAVE THE TROCAR AND I BELIEVE WE ALSO HAVE THE BROKEN-OFF PIECE, AND YOU TENTATIVELY CAN PICK IT UP WEDNESDAY. NO OTHER TROCAR WAS SUBSTITUTED OR USED SINCE THE PROCEDURE WAS BASICALLY FINISHED. ADDITIONAL INFORMATION PROVIDED BY USER FACILITY ON 04NOV2025: THE BEND/BREAK OCCURRED AT THE TAB. THE BEND/BREAK WAS IDENTIFIED DURING USE. THE TROCAR WAS INSERTED WITH ROTATION. THERE WAS NO DIFFICULTY DURING INSERTION. THIS TROCAR WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547067 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GB. EVENT DESCRIPTION: THE PLASTIC PART (CANNULA WING TAB) WAS BROKEN DURING THE USE OF THE TROCAR." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 17SEP2025 FROM AMK REGIONAL SALES MANAGER: "THE BEND/BREAK WAS IDENTIFIED AT DURING INSERTION. THE TROCAR WAS INSERTED LIKE ROTATED IN ALTERNATING CLOCKWISE. THERE WAS NO DIFFICULTY DURING INSERTION. THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK. THE BREAK DID NOT CAUSE PARTICULATION. THIS TROCAR WAS NOT USED WITH A ROBOT. AT THE TIME OF THE INCIDENT, THERE WAS A HAND ON THE CANNULA." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098733 ↗
• MalfunctionJul 31, 2025Fracture; Fracture

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE FOLLOWING TROCARS SHATTERED DURING A PROCEDURE ¿ REF: CFR73 & CTR73. I HAVE IN MY POSSESSION THE AFFECTED TROCARS FOR YOU TO COLLECT. TWO SEPARATE OCCURRENCES ¿ TEAM WAS UNABLE TO COLLECT WRAPPING FOR LOT NUMBERS. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 28JUL2025: HELLO, I SENT THIS TO THE UNIVERSITY HOSPITAL TEAM WHEN YOU SENT IT TO ME BUT I HAVEN¿T HEARD ANYTHING BACK YET. I SPOKE TO [ACCOUNT MANAGER] ON MONDAY 04 AUG 2025 REGARDING COMPLAINT (B)(4). HE MENTIONED THAT HE SHARED THE ADDITIONAL QUESTIONS ALONG WITH THE STATUS OF THE DEVICES COLLECTED IN RELATION TO THIS COMPLAINT WITH THE HOSPITAL STAFF BUT HAS NOT HEARD BACK. HE MENTIONED THAT TO HIS KNOWLEDGE THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT. ADDITIONAL INFORMATION OBTAINED FROM [APPLIED MEDICAL CLINICAL DEVELOPMENT TEAM MEMBER] VIA EMAIL ON 28JUL2025: I SPOKE TO [ACCOUNT MANGER] ON MONDAY 04 AUG 2025 REGARDING COMPLAINT (B)(4). HE MENTIONED THAT HE SHARED THE ADDITIONAL QUESTIONS ALONG WITH THE STATUS OF THE DEVICES COLLECTED IN RELATION TO THIS COMPLAINT WITH THE HOSPITAL STAFF BUT HAS NOT HEARD BACK. HE MENTIONED THAT TO HI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681829 ↗
• MalfunctionMay 15, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING). EVENT DESCRIPTION: PLASTIC TAB ON CANNULA THAT IS PUSHED IN TO REMOVE SEAL HOUSING BROKE UPON DEMONSTRATION PLEASE NOTE, THE UNITS WERE NOT USED IN A CLINICAL SETTING. THE DEVICES WERE USED FOR SEVERAL EDUCATION TABLES AS WELL AS IN-SERVICES HELD BETWEEN 2/16/2025-5/01/2025. THE DEMOS TOOK PLACE AT [HOSPITAL NAME]. I ONLY HAVE ONE SAVED STERILE PACKING THAT SHOWS A LOT NUMBER OF 1533196 (MATERIAL # FOR THAT LOT IS 101219401). ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 16MAY2025: UNSURE WHETHER THE LOT NUMBER OF THE DEVICES THAT MALFUNCTIONED WAS THE SAME AS THE STERILE UNIT THAT IS AVAILABLE. NO PROCEDURE BEING PERFORMED DURING DEMONSTRATION. NO CONCOMITANT DEVICES USED DURING DEMONSTRATION. BEND/BREAK OCCURRED ON THE OBTURATOR TABS. THE BEND/BREAK WAS IDENTIFIED DURING DEMONSTRATION OF PRODUCT. PATIENT STATUS: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028358 ↗
• MalfunctionMay 15, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING). EVENT DESCRIPTION: PLASTIC TAB ON CANNULA THAT IS PUSHED IN TO REMOVE SEAL HOUSING BROKE UPON DEMONSTRATION PLEASE NOTE, THE UNITS WERE NOT USED IN A CLINICAL SETTING. THE DEVICES WERE USED FOR SEVERAL EDUCATION TABLES AS WELL AS IN-SERVICES HELD BETWEEN 2/16/2025-5/01/2025. THE DEMOS TOOK PLACE AT [HOSPITAL NAME]. I ONLY HAVE ONE SAVED STERILEPACKING THAT SHOWS A LOT NUMBER OF 1533196 (MATERIAL # FOR THAT LOT IS 101219401). ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 16MAY2025: UNSURE WHETHER THE LOT NUMBER OF THE DEVICES THAT MALFUNCTIONED WAS THE SAME AS THE STERILE UNIT THAT IS AVAILABLE. NO PROCEDURE BEING PERFORMED DURING DEMONSTRATION. NO CONCOMITANT DEVICES USED DURING DEMONSTRATION. BEND/BREAK OCCURRED ON THE OBTURATOR TABS. THE BEND/BREAK WAS IDENTIFIED DURING DEMONSTRATION OF PRODUCT. PATIENT STATUS: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028158 ↗
• MalfunctionMay 15, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING). EVENT DESCRIPTION: PLASTIC TAB ON CANNULA THAT IS PUSHED IN TO REMOVE SEAL HOUSING BROKE UPON DEMONSTRATION PLEASE NOTE, THE UNITS WERE NOT USED IN A CLINICAL SETTING. THE DEVICES WERE USED FOR SEVERAL EDUCATION TABLES AS WELL AS IN-SERVICES HELD BETWEEN 2/16/2025-5/01/2025. THE DEMOS TOOK PLACE AT [HOSPITAL NAME]. I ONLY HAVE ONE SAVED STERILE PACKING THAT SHOWS A LOT NUMBER OF 1533196 (MATERIAL # FOR THAT LOT IS 101219401) ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 16MAY2025: UNSURE WHETHER THE LOT NUMBER OF THE DEVICES THAT MALFUNCTIONED WAS THE SAME AS THE STERILE UNIT THAT IS AVAILABLE. NO PROCEDURE BEING PERFORMED DURING DEMONSTRATION. NO CONCOMITANT DEVICES USED DURING DEMONSTRATION. BEND/BREAK OCCURRED ON THE OBTURATOR TABS. THE BEND/BREAK WAS IDENTIFIED DURING DEMONSTRATION OF PRODUCT. PATIENT STATUS: NA (THE UNITS WERE NOT USED IN A CLINICAL SETTING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027765 ↗
• MalfunctionMay 14, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPIC MEDIASTINAL TUMOR RESECTION. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. DURING SURGERY, THE TIP OF THE OBTURATOR WAS CRACKED. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A HOSPITAL INVENTORY NEW CTR73 AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS NOT BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CTR73 AND THE PROCEDURE WAS COMPLETED PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022935 ↗
• MalfunctionMay 5, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP STRUCTURED LOOP COLOSTOMY REVISION. EVENT DESCRIPTION: DURING THE REMOVAL OF THE CAP, THE CLIP HOLDING THE CAP BROKE OFF ADDITIONAL INFORMATION PROVIDED BY THE FACILITY ON 21APR2025: LATCH TABS BREAK. UNKNOWN IF TABS WERE BEING PINCHED AT THE TIME OF BREAKAGE. INTERVENTION: WAS COMPLETING CASE BY REMOVING SPECIMEN THROUGH PORT- NO LONGER NEEDED. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961894 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC CHOLE. EVENT DESCRIPTION: THIS WAS FROM A DR. [NAME}/DR. [NAME] ROBOTIC CHOLECYSTECTOMY ON (B)(6) 2025 AROUND 0930 DURING TROCAR INSERTION. FORTUNATELY, THE TROCAR APPEARS TO HAVE BROKEN COMPLETELY IN HALF. I HAVE IT IN MY OFFICE WITH THE PACKAGING INFORMATION. I PLACED A MIDAS REPORT DUE TO PATIENT INVOLVEMENT. PATIENT WAS NOT INJURED. PATIENT STATUS: PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910400 ↗
• MalfunctionFeb 6, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACIC PROCEDURE WITH WEDGE RESECTION. EVENT DESCRIPTION: MODEL #: CTR73. LOT #: UNK. THE PROCEDURE WAS A THORACIC PROCEDURE WITH WEDGE RESECTION. THE SURGEON INSERTED THE TROCAR WITH EXCESSIVE FORCE. THE CANNULA BROKE BUT WAS NOT NOTICED UNTIL THE END. THE PROCEDURE WAS COMPLETED WITH BROKEN TROCAR, AND THE SURGEON DID NOT KNOW THE TROCAR WAS BROKEN UNTIL HE PUT A CAMERA IN AT THE END. THE TROCAR BROKE IN ONE PIECE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON (B)(6)2025: THERE WAS DIFFICULTY DURING INSERTION, BECAUSE THE SURGEON DID NOT ROTATE THE TROCAR. HE SIMPLY USED BLUNT DOWNWARD FORCE IN A VERY NARROW SPACE. THE TROCAR WAS NOT USED WITH A ROBOT. THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE SAME TIME OF THE INCIDENT. INTERVENTION: COMPLETED PROCEDURE WITH BROKEN TROCAR, THE SURGEON DID NOT KNOW THE TROCAR WAS BROKEN UNTIL HE PUT A CAMERA IN AT THE END. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322692 ↗
• MalfunctionNov 12, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC THORACIC CASE: EVENT DESCRIPTION: DURING A LAPAROSCOPIC THORACIC PROCEDURE, 2 PIECES OF THE TROCAR BROKE OFF INSIDE OF THE PATIENT. THEY WERE ABLE TO REMOVE THE 2 PIECES OF PLASTIC. NOTE FROM THE PHYSICIAN ABOUT THE PERFORMING PHYSICIAN: THE SURGEON IS FAIRLY NEW TO THE PROCEDURE SO IT COULD BE USER ERROR. THE PRODUCT IS EXPECTED TO RETURN. TYPE OF INTERVENTION: REPLACED WITH ANOTHER TROCAR TO FINISH. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669002 ↗
• MalfunctionMay 15, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAR EVENT DESCRIPTION: DURING THE USE OF THE DEVICE, ONE OF THE CANNULA TABS WERE BROKEN. THE DEVICE WAS REPLACED WITH A NEW DEVCIE. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326328 ↗
• MalfunctionApr 4, 2024Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC LEFT COLECTOMY EVENT DESCRIPTION: PRODUCT: CTR73. "TOWARDS THE END OF THE SURGERY, THE SURGEON (DR. [NAME]) WAS PULLING OUT THE SCOPE FROM THE CTR73 TROCAR. WHEN THE SCOPE WAS BEING PULLED OUT, IT WAS PULLED OUT IN A WEIRD ANGLE, WHICH CAUSED THE CANNULA OF THE TROCAR TO SNAP IN HALF. THEY WERE ABLE TO RETRIEVE THE TROCAR PIECES." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED REPRESENTATIVE VIA EMAIL ON 27MAR2024: "BREAK APPEARS TO BE IN THE CENTER OF THE CANNULA. THE BREAK APPEARS TO BE A CLEAN BREAK. ALL PIECES WERE ACCOUNTED FOR AND WERE RETRIEVED." INTERVENTION: THE SURGERY WAS FINISHED WITH THE SAME INSTRUMENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047682 ↗
• MalfunctionFeb 6, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRECTOMY. EVENT DESCRIPTION: PRODUCT: 12X100MM KII OPT ZTHR TROCAR. BEFORE THE OPERATION WAS COMPLETED, WHILE ATTEMPTING TO RETRIEVE THE SPECIMEN, FRAGMENTS OF THE TROCAR WERE DISCOVERED INSIDE THE ABDOMINAL CAVITY. THE OPERATOR HAS SUCCESSFULLY REMOVED THE FRAGMENTS. NO IMPACT TO THE PATIENTS. PRODUCT AVAILABLE FOR RETURN: 1 TROCAR. ADDITIONAL INFORMATION RECEIVED ON 24JAN2024 VIA EMAIL BY DISTRIBUTOR: THE FRAGMENT WAS FROM THE CANNULA. THE SURGERY WAS FINISHED WITH THE SAME DEVICE, SINCE THE FRAGMENTS WERE ONLY DISCOVERED TOWARDS THE END OF THE SURGERY. 5MM GRASPER WAS USED WITH THE TROCAR (THAT MIGHT HAVE CAUSED THE INCIDENT). PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655833 ↗
• MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: PARTIAL NEPHRECTOMY EVENT DESCRIPTION: THE [COMPETITOR DEVICE] MANUAL STAPLER SEEMED TO BE GETTING STUCK IN THE 12MM TROCAR, AND IT ENDED UP PULLING THE ENTIRE TROCAR OUT WHEN HE REMOVED THE STAPLER. ON THE BACK TABLE THEY WERE INSERTING THE STAPLER INTO THE TROCAR TO TEST IT AND NOTICED IT WAS GETTING CAUGHT ON SOMETHING AND TOOK A VIDEO TO DOCUMENT IT. THEY CONTINUED TO TEST IT AND THEN THE CLEAR SEAL INSIDE THE TROCAR POPPED OUT. THEY SENT ME THE VIDEO, PICTURES, AND THE OFFICIAL COMPLAINT DOCUMENT THEY FILLED OUT FOR THIS INSTANCE WHICH INCLUDES THE TYPE OF STAPLER AND LOAD THEY WERE USING. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 12JAN2024 FROM APPLIED MEDICAL REPRESENTATIVE: THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING "GOOD". THE CASE WAS COMPLETED WITH A [COMPETITOR DEVICE] 12MM TROCAR. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS THROWN AWAY AFTER THE CASE. INTERVENTION: OPENED A [COMPETITOR DEVICE] 12MM TROCAR TO COMPLETE THE CASE. PATIENT STATUS: GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616920 ↗
• MalfunctionDec 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #(B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: OCTOBER 6, 2023. 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 - CTR73 LOT #1495004 (2 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250378 ↗
• MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #(B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: AUGUST 4,2023. 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 - CTR73 LOT #1488142 (1 EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STAUTS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810116 ↗
• MalfunctionMay 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). [DISTRIBUTOR] INCOMING INSPECTION PO #23096. THIS IS A COMPLAINT FROM [DISTRIBUTOR]EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: MARCH 17,2023. 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: CTR73 LOT # 1470386 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935337 ↗
• 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# (B)(4). 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. 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 - CTR73 LOT #1461369 (1 EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274487 ↗
• MalfunctionJan 30, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: RETROPERITONEOSCOPIC TOTAL NEPHROURETERECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), MFR REPORT # 2027111-2023-00325. COMPLAINT 2 OF 2: (B)(4), MFR REPORT # 2027111 2023 00326. REPORT FROM THE SALES REP ONE OF THE WING TABS OF THE CANNULA WAS BROKEN WHEN THE SEAL WAS REMOVED AND A SUCTION OR SOMETHING WAS PERFORMED. INSTEAD OF REPLACING THE TROCAR, THE SEAL PART WAS FIXED WITH TAPE, AND THE PROCEDURE WAS COMPLETED. IT HAS ALSO OCCURRED WITH ANOTHER CTR73 USED IN THE SAME PATIENT. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. ONE OF THE WING TABS OF THE CANNULA WAS BROKEN. THE AREA AROUND THE BROKEN TAB WAS SCRATCHED AS IF IT HAD BEEN RUBBED. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. INTERVENTION: INSTEAD OF REPLACING THE TROCAR, THE SEAL PART WAS FIXED WITH TAPE, AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269521 ↗
• MalfunctionJan 30, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: RETROPERITONEOSCOPIC TOTAL NEPHROURETERECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: 2023-000150, MFR REPORT # 2027111-2023-00325. COMPLAINT 2 OF 2: 2023-000151, MFR REPORT # 2027111-2023 00326. REPORT FROM THE SALES REP ONE OF THE WING TABS OF THE CANNULA WAS BROKEN WHEN THE SEAL WAS REMOVED AND A SUCTION OR SOMETHING WAS PERFORMED. INSTEAD OF REPLACING THE TROCAR, THE SEAL PART WAS FIXED WITH TAPE, AND THE PROCEDURE WAS COMPLETED. IT HAS ALSO OCCURRED WITH ANOTHER CTR73 USED IN THE SAME PATIENT. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. ONE OF THE WING TABS OF THE CANNULA WAS BROKEN. THE AREA AROUND THE BROKEN TAB WAS SCRATCHED AS IF IT HAD BEEN RUBBED. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. INTERVENTION: INSTEAD OF REPLACING THE TROCAR, THE SEAL PART WAS FIXED WITH TAPE, AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269490 ↗