Kii Optical Access System CFR73Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00607915119898), received between May 19, 2016 and Jul 31, 2025 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (34 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 47 reports, in the reporter's own words as published by the FDA.

• 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 2025-001996. 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681794 ↗
• MalfunctionMay 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: A PART OF THE DOUBLE-DUCKBILL WAS DAMAGED. THE DOCTOR NOTICED IT WHEN HE FELT A SNAG WHEN PUTTING GAUZE IN AND OUT. THE FRAGMENT WAS REMOVED FROM THE BODY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A HOSPITAL INVENTORY NEW CFR73 AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CFR73 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 21960540 ↗
• MalfunctionDec 20, 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: (B)(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. 1) 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. 2) AIRLIKE OBJECT IN POUCH - CFR73 LOT #1495020 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369239 ↗
• MalfunctionAug 21, 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: JUNE 26,2023. 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 - CFR73, LOT #1483317 (1 EA.) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592277 ↗
• MalfunctionMay 19, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NEPHRECTOMY BY [NAME] ROBOT. EVENT DESCRIPTION: AFTER THE INSTRUMENT WAS PROPERLY SET UP AND INSERTED INTO THE ABDOMINAL CAVITY, THE ENDOSCOPE WAS INSERTED. HOWEVER, IT WAS DISCOVERED THAT THE TIP OF THE TROCAR HAD FRACTURED, CAUSING FRAGMENTS TO FALL INSIDE THE PATIENT'S BODY. THE MEDICAL PERSONNEL HAVE ALREADY SUCCESSFULLY REMOVED THE FRAGMENTS FROM THE PATIENT'S BODY. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 17MAY2023 VIA EMAIL FROM THE DISTRIBUTOR THE TROCAR WAS ROTATED IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTIONS. THERE WAS NO DIFFICULTY DURING INSERTION. THE ROBOT MODEL IS XI, WHICH DOES NOT UTILIZE CLAMPS. IT FIRST SETS CFR73 AND THEN PROCEEDS TO ENTER THE TROCAR USING THE CAMERA FROM [ROBOT]. ENDOSCOPE WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. TYPE OF INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964240 ↗
• MalfunctionApr 24, 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 (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: MARCH 6,2023 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 - CFR73 LOT #1477736 (1 EA.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802792 ↗
• MalfunctionNov 28, 2022Device 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: (B)(6) 2022. I) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR THE FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CFR73, LOT #1461355(1 EA.). PRODUCT AVAILABLE FOR RETURN. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870448 ↗
• MalfunctionJul 15, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [FACILITY] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: MAY 23, 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 - CFR73 LOT #1447351 (1 EA.) PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033702 ↗
• MalfunctionApr 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [FACILITY] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: FEBRUARY 18, 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 - CFR73 LOT #1439907(1 EA.) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). INTERVENTION NA (INCOMING INSPECTION)1 EA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059239 ↗
• MalfunctionFeb 4, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: FACILITY: INCOMING INSPECTION PO# (B)(6). THIS IS A COMPLAINT FROM FACILITY EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: DECEMBER 8, 2021. 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: CFR73 LOT #1432195 (1 EA.) PATIENT STATUS: NOT APPLICABLE. TYPE OF INTERVENTION NOT APPLICABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13459660 ↗
• MalfunctionMay 22, 2018Break; Break

  PROCEDURE PERFORMED: DIAGNOSTIC LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS INCIDENT DESCRIPTION: "RECEIVED A PHONE CALL FROM HEALTH SERVICES MANAGER AT [HOSPITAL NAME] AT 0900HRS THIS MORNING STATING THAT ONE OF OUR TROCARS HAD BROKEN OFF DURING A PROCEDURE LAST NIGHT. THE PROCEDURE WAS FOR A DIAGNOSTIC LAP CASE FOR ENDOMETRIOSIS. SPOKE TO ONE OF THE NURSES INVOLVED IN THE CASE AND SHE STATED THAT THE TROCAR IN QUESTION DID NOT BREAK DURING ENTRY INTO THE ABDOMEN. THE TROCAR BROKE ON INSERTION OF A 5MM LATERAL PORT. THE NURSE STATED THAT THE SURGEON INVOLVED WAS SHOWING AN INSERTION TECHNIQUE TO THE REGISTRAR. THE REGISTRAR INSERTED THE 5MM LATERAL PORT AND IT CONNECTED WITH THE 12MM PORT. THE REGISTRAR TILTED THE 5MM PORT AND THAT IS WHEN THE 12MM TROCAR SNAPPED. THE SNAPPED PIECE OF PLASTIC WAS NOT FOUND AND THE PATIENT HAS BEEN INFORMED." PATIENT STATUS: PATIENT INJURY OR ILLNESS DID NOT OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531902 ↗
• MalfunctionDec 15, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC NEPHRECTOMY". "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SEPTUM FRAGMENTATION. REPORT FROM THE SALES REP: A FOREIGN MATERIAL FELL OFF INSIDE ABDOMINAL CAVITY. IT WAS REMOVED FROM PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED. DURING INSPECTION ON THE TROCAR POST-TREATMENT, THE CUSTOMER NOTED THE TROCAR VALVE WAS FRAGMENTED AND THE FOREIGN MATERIAL COMES FROM THE TROCAR VALVE. INTRAPERITONEAL IRRIGATION WAS PERFORMED DURING THE CASE. NO PATIENT INJURY. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE DDB WAS REMOVED BY THE CUSTOMER FOR INSPECTION. THE SEPTUM WAS FRAGMENTED. THE RETURNED FRAGMENT (SIZE: 1.5MM X 2.5MM) MATCHED THE MISSING LOCATION ON THE SEPTUM. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4). TYPE OF INTERVENTION: "IT WAS REMOVED FROM PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED". PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121353 ↗
• MalfunctionDec 7, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: "VENTRAL HERNIA REPAIR." EVENT DESCRIPTION: RECEIVED VIA MAUDE DATABASE, REPORT #MW5073032 ON 10-NOV-2017: "CANNULA CAP POPPED OFF AND FELL ON THE FLOOR." TYPE OF INTERVENTION: N/A. PATIENT STATUS: "0 PATIENTS WERE INVOLVED IN THE EVENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098576 ↗
• MalfunctionOct 26, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC NEPHRECTOMY" EVENT DESCRIPTION: "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SEPTUM FRAGMENTATION: REPORT FROM THE SALES REP: THE CUSTOMER NOTED THAT A FRAGMENT OF THE TROCAR SEPTUM FELL OFF INSIDE ABDOMINAL CAVITY. HE/SHE REMOVE THE FRAGMENT FROM ABDOMINAL CAVITY, AND CONFIRMED IT MATCHED THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE PROCEDURE(LAPAROSCOPIC NEPHRECTOMY) WAS SUCCESSFULLY COMPLETED WITH THE EVENT UNIT. THE PATIENT STATUS IS OK. THE CER CHECK LIST IS UNAVAILABLE. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE DOUBLE DUCK BILL WAS REMOVED FROM THE SEAL BY THE FACILITY FOR INSPECTION. THE SEPTUM WAS FRAGMENTED. THE RETURNED FRAGMENT(SIZE: 7.0 MM X 6.5 MM) MATCHED THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." TYPE OF INTERVENTION: "HE/SHE REMOVE THE FRAGMENT FROM ABDOMINAL CAVITY, AND CONFIRMED IT MATCHED THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE PROCEDURE(LAPAROSCOPIC NEPHRECTOMY) WAS SUCCESSFULLY COMPLETED WITH THE EVENT UNIT." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980379 ↗
• MalfunctionOct 6, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC PROSTATECTOMY." EVENT DESCRIPTION: "VALVE FRAGMENTATION." REPORT FROM THE SALES REP: DURING LAPAROSCOPIC PROSTATECTOMY, THE VALVE INSIDE THE TROCAR WAS FRAGMENTED AT THREE SECTIONS. TWO FRAGMENTS MATCHING THE TWO MISSING SECTIONS WERE REMOVED FROM ABDOMINAL CAVITY. HOWEVER, THE CUSTOMER IS NOT SURE WHETHER THE REST OF THE FRAGMENTS REMAINED INSIDE ABDOMINAL CAVITY OR IT WAS REMOVED BECAUSE OF INTRAPERITONEAL IRRIGATION. THE SIZES OF THE FRAGMENTS WERE APPROX.1 MM. CER CHECK LIST IS UNAVAILABLE. INITIAL INVESTIGATION REPORT BY AOMORI OLYMPUS THE EVENT UNIT WAS NOT RETURNED TO OLYMPUS. THE INCIDENT WILL BE INFORMED AMR OF FOR FURTHER EVALUATION. (B)(4). THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6921274 ↗
• MalfunctionSep 14, 2017Break; Break

  PROCEDURE PERFORMED: "ESOPHAGEAL CANCER SURGERY." EVENT DESCRIPTION: "WHEN THEY WANT TO FINISHED THE SURGERY, AND THEN FOUND THE TIP WAS BROKEN. SURGEONS PICK UP FRAGMENTS FROM PATIENT. PLEASE SEE THE ATTACHMENT." TYPE OF INTERVENTION: UNK. PATIENT STATUS: "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866908 ↗
• MalfunctionJul 13, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED - "LADG". "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." "REPORT FROM THE SALES REP: DURING A PROCEDURE, THE CUSTOMER NOTED A RUBBER FRAGMENT INSIDE ABDOMINAL CAVITY. THE FRAGMENT WAS REMOVED FROM THE PATIENT USING A GRASPER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY AND BLEEDING. THE DDB WAS CUT FOR THE INSPECTION OF THE CUSTOMER. PLEASE SEE THE CER CHECK LIST FOR INSERTED INSTRUMENTS INTO THE TROCAR. "INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM WAS FRAGMENTED. THE RETURNED RUBBER MATERIAL(THE SIZE: APPROX.. 3.5MM X 2.0MM) MATCHED THE MISSING LOCATION ON THE SEPTUM. THE UNIT WILL BE RETURNED TO (B)(4) FOR FURTHER EVALUATION. ADMIN#(B)(4)." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712289 ↗
• MalfunctionJun 14, 2017Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC NEPHRECTOMY, EVENT DESCRIPTION: "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." REPORT FROM THE SALES REP: THE SURGEON NOTED THAT WHEN INSERTING THE SECOND TROCAR(MODEL NAME:UNKNOWN) AS WORKING PORT, THE DISTAL END OF THE CANNULA OF THE FIRST TROCAR AS CAMERA PORT CONTACTED THE NON-SHARP TIP OF THE OBTURATOR OF THE SECOND TROCAR, CAUSING THE DISTAL END OF THE FIRST TROCAR TO BE FRAGMENTED INSIDE ABDOMINAL CAVITY. ON CONFIRMING THE FRAGMENT, IT WAS REMOVED FROM PATIENT. HE/SHE DETERMINED THAT THE FRAGMENT MATCHED A MISSING PORTION ON THE CANNULA. THE EVENT TROCAR WAS REPLACED WITH NEW ONE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SECOND TROCAR WITHOUT ANY FRAGMENTS WAS DISPOSED OF. HE/SHE CANNOT ADMIT THE OBTURATOR SECOND TROCAR WITH A ROUND-SHAPED AND NON-SHARP TIP CONTACT WITH CANNULA OF THE FIRST TROCAR WITHOUT ANY ANGULAR POINTS CAUSES THE INCIDENT BECAUSE THEY DON'T GET STUCK IN EACH OTHER. INITIAL INVESTIGATION REPORT BY AOMORI OLYMPUS: THE EVENT UNIT AND ONE(1) FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE DISTAL END OF THE CANNULA WAS MISSING A PORTION. THE RETURN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641562 ↗
• MalfunctionMar 16, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP: THE SEPTUM WAS DAMAGED AND THE RUBBER FRAGMENT WAS FOUND OUTSIDE OF THE PATIENT CAVITY. THE DURATION OF THE PROCEDURE WAS APPROX. 7 TO 8 HOURS. ULTRASONIC ENERGY DEVICE WAS INSERTED INTO THE EVENT TROCAR. INITIAL INVESTIGATION REPORT BY (B)(6) OLYMPUS: THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SHIELD HAD NO VISIBLE DAMAGE; THE DDB HAD BEEN CUT BY THE CUSTOMER. THE REPORTED DAMAGE TO THE SEPTUM WAS CONFIRMED; THE SEPTUM WAS MISSING A PORTION; AFTER PUTTING THE RETURNED FRAGMENT(APPROX. 9 MM X 11 MM, ONTO THE DAMAGED SEPTUM LOCATION, TWO MISSING LOCATIONS WERE CONFIRMED. THE SIZES OF TWO MISSING LOCATIONS (A AND B) WERE RESPECTIVELY APPROX. 1.6MM×1.5MM AND 1.4MM×2.2MM. THE UNIT WILL BE RETURNED TO (B)(6) FOR FURTHER EVALUATION. ADMIN#(B)(4)." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412120 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC HEPATECTOMY - "THIS IS THE COMPLAINT FROM THE MARKET. PHYSICIAN NOTICED DEBRIS INSIDE PATIENT BODY FOUR HOURS LATER FROM THE BEGINNING OF A PROCEDURE. THE DEBRIS WAS RETRIEVED. CUSA EXCEL PROBE AND ULTRASONIC PROBE WERE USED THROUGH THIS UNIT. PATIENT STATUS: UNKNOWN AOMORI OLMYPUS RECEIVED THE UNIT AND A PIECE OF BLACK COLOR DEBRIS. THE DEBRIS WAS COMPLETELY FIT THE VALVE INSIDE THE SEAL. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE EVENT UNIT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6373020 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "THIS IS THE COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. PHYSICIAN NOTICED A BLACK DEBRIS IN THE PATIENT BODY DURING A PROCEDURE AND PICKED IT UP. IT WAS CONFIRMED AS A PIECE OF RUBBER. PLEASE CONFIRM THAT THE DEBRIS IS A PORTION OF TROCAR COMPONENTS. PHYSICIAN USED NOT ONLY CFR73 BUT ALSO USED CRF03 AND D0R47 AT THE SAME PROCEDURE AND WANTS TO CONFIRM FROM WHAT MODEL THE DEBRIS CAM OUT OF THE THREE UNITS, IF YOU CAN FIGURE IT OUT. THE ACTUAL UNIT THAT USED DURING THE PROCEDURE WAS NOT RETURNED FROM THE HOSPITAL SINCE IT WAS DISCARDED. OLYMPUS RECEIVED ONLY A BLACK COLOR SMALL PIECE LOOKS LIKE A PORTION OF SEPTUM. THE PIECE WILL BE RETURNED TO APPLIED MEDICAL FOR FURTHER INVESTIGATION. OLYMPUS CONFIRMED A SMALL SCRATCHING DENT ON THE DEBRIS. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE EVENT UNIT. THIS INCIDENT IS TREATED AS URGENT MATTER SINCE IT'S COMPONENT DROP OFF INCIDENT. (B)(4)." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372909 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO: (B)(4). NO CREDIT OR REPLACEMENT IS NEEDED AS THE MODEL NUMBER COULD NOT BE IDENTIFIED. THE EVENT UNIT AND A FRAGMENT WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "THE SEPTUM WAS FOUND TO BE DAMAGED AT TWO SITES DURING A PROCEDURE. ONE OF THE BROKEN PIECES WAS RETRIEVED. AS THE OTHER PIECE COULD NOT BE FOUND, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED AND THE PROCEDURE WAS COMPLETED. THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE DDB HAD BEEN DETACHED FROM THE SEAL BY THE CUSTOMER FOR INSPECTION AND NO DAMAGE WAS FOUND WITH IT. THE SEPTUM HAD TWO MISSING PORTIONS; THE LARGER ONE MATCHED THE RETURNED FRAGMENT IN SHAPE. THE FRAGMENT MEASURED APPROX. 3.8 MM X 2.3 MM; NO FRAGMENT MATCHING THE SMALLER MISSING PORTION WAS RETURNED. AS THE MODEL NUMBER COULD NOT BE IDENTIFIED, NO CREDIT OR REPLACEMENT IS NEEDED. THE UNIT AND THE FRAGMENT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#: (B)(4)." INCORRECT FACILITY WAS ORIGINALLY PROVIDED, THE CORRECT FACILITY IS (B)(6) HOSPITAL. PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372500 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO: (B)(4). ONE (1) EVENT UNIT AND A FRAGMENT WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "THE SEPTUM WAS FOUND TO BE DAMAGED AFTER A PROCEDURE. ONE (1) EVENT UNIT AND A FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SEPTUM WAS FOUND TO HAVE A MISSING PORTION THAT SEEMED TO MATCH THE FRAGMENT IN SHAPE. THE FRAGMENT MEASURED APPROX. 1.5 MM X 1.2MM. THE UNIT AND THE FRAGMENT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#: (B)(4)." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372483 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY- "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). THE EVENT UNIT AND A FRAGMENT WILL BE RETURNED TO AMR. PLEASE REFER TO THE INVESTIGATION SHEET FOR COMPLAINT. A RUBBER FRAGMENT WAS FOUND INSIDE THE PATIENT DURING A LAPAROSCOPIC GASTRECTOMY. THE FRAGMENT WAS RETRIEVED. THE EVENT UNIT AND A RUBBER FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SEPTUM HAD A MISSING PORTION AND IT MATCHED THE FRAGMENT IN SHAPE. THE FRAGMENT HAD A PIN HOLE AND MEASURED APPROX. 8.2 MM X 7.1 MM. THE UNIT AN THE FRAGMENT WILL RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4)."PATIENT STATUS- "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372194 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  GS SURGERY FOR LIVER /CHOLECYST/PANCREAS - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). THE EVENT UNIT AND TWO SHEETS OF TYVEK WILL BE RETURNED TO AMR. NO CREDIT OR REPLACEMENT IS NEEDED AS MODEL # AND LOT # CANNOT BE IDENTIFIED. PLEASE REFER TO THE INVESTIGATION SHEET FOR COMPLAINT ." COMPLAINT SHEET - "THE SEPTUM WAS DAMAGED WHEN AN ECHO PROBE WAS INSERTED/WITHDRAWN INTO/FROM THE SEAL AND THE FRAGMENT FELL INSIDE THE BODY. COMBINED INSTRUMENTS: ECHO PROBE, 10 MM RIGID ENDOSCOPE, POWERED ECHELON, HARMONIC ACE+, LIGASURE BLUNT, LIGASURE MARYLAND, GRASPER, DISSECTOR, SCISSORS, AND NEEDLE DRIVER~ PROCEDURE: GS SURGERY FOR LIVER/CHOLECYST/PANCREAS. THE EVENT UNIT AND TWO SHEETS OF TYVEK WERE RETURNED TO OLYMPUS. ONE OF THE TYVEK SHEETS SHOWED THE MODEL # OF CFR73 WITH LOT # OF 1251017. THE OTHER SHEET SHOWED THE MODEL # OF CFS22 AND THE LOT # OF 1247889. OLYMPUS WAS UNABLE TO IDENTIFY WHICH MODEL / LOT #S ARE CORRECT,THUS WOULD LIKE AMR TO REVIEW THE MANUFACTURING RECORDS FOR THE BOTH LOTS, NO CREDIT OR REPLACEMENT IS NEEDED. UPON VISUAL INSPECTION,THE DDB WAS FOUND TO HAVE A CUT. THE SEPTUM WAS TORN AND ONE OF THE SHIELDS STUCK OUT OR THE TEAR, THE SEPTUM APPEARED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370916 ↗