Kii Optical Access System CFR03Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00607915119881), received between Jan 3, 2017 and Oct 22, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Optical Distortion; Optical Distortion

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: LINKED COMPLAINTS: (B)(4). COMMUNICATION BETWEEN APPLIED MEDICAL TERRITORY MANAGER AND CD TEAM MEMBER VIA EMAIL ON 14OCT2024: I JUST RECEIVED A COMPLAINT FROM A SURGEON SAYING THAT USING CFR03 OR CTR03 IT IS NOT POSSIBLE TO FOCUS ON TISSUE DURING PENETRATION, SO THE VERY IDEA OF OPTICAL TROCAR IS LOST. HE USES A 5 MM [BRAND] OPTICAL SYSTEM. HE SAYS THAT HE HAD NO PROBLEM WITH A [BRAND] BUT ONLY WITH OUR DEVICES. ADDITIONAL INFORMATION WAS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA PATIENT COMPLAINT FORM ON 14OCT2024: A COMPLAINT HAS COME FROM A SURGEON THAT IT IS NOT POSSIBLE TO FOCUS ON THE TISSUE USING CFR03 OR CTR03 WITH A 5MM [BRAND] OPTICS. THE TROCARS WORKED WELL EXCEPT THE ISSUE WITH FOCUSING AT TISSUE DURING PENETRATION AND WAS NOT TAKEN CARE OF AFTER SURGERY. NOTE - THIS COMPLAINT IS NOT REGARDING A SPECIAL OCCASION BUT A GENERAL COMPLAINT FROM THE SURGEON. COMMUNICATION BETWEEN APPLIED MEDICAL TERRITORY MANAGER AND CD TEAM MEMBER VIA EMAIL ON 15OCT2024: I FINALLY MANAGED TO GET HOLD OF THE SURGEON ON PHONE, AND IT SEEMS LIKE IT IS NOT REALLY A COMPLIANT BUT A SOLVABLE ISSUE DUE TO THE COMBINATION OF TROCAR/CAMERA. FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510644 ↗
• 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 #24044,24042,24047. 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 16,2023. 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 - CFR03 LOT #1497056 ((B)(4) EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366496 ↗
• MalfunctionJun 8, 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. 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 - CFR03 LOT #1477712 (1 EA.) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT) TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093495 ↗
• MalfunctionApr 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC, REPAIR OF ANTERIOR ABDOMINAL HERNIA (EPIGASTRIC, INCISIONAL, VENTRAL, UMBILICAL, SPIGELIAN), LAPAROSCOPIC, INTAL, INC IMPLNTN OF MESH WHEN PERF, TOT LEN OF DEF; < 3 CM; INCARC OR STRANG DETAILED DESCRIPTION OF EVENT: COMPLAINT CREATED BASED OFF MEDWATCH REPORT. UF/IMPORTER REPORT # (B)(4). HAIR FOUND ON THE TROCAR DURING STERILE FIELD SETUP. PRODUCT IS AVAILABLE FOR RETURN. PATIENT STAUTS: NI (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: THE DEFECT WAS IDENTIFIED PRIOR TO THE START OF THE CASE AND THE ITEM WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825412 ↗
• MalfunctionApr 17, 2023Contamination

  HAIR FOUND ON THE TROCAR DURING STERILE FIELD SETUP.

  Patient problems: Insufficient Information

  MAUDE report 16750910 ↗
• MalfunctionAug 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC TOTAL HYSTERECTOMY. EVENT DESCRIPTION: EVENT 1 OF 2: REPORT #2027111-2021-00599. EVENT 2 OF 2: REPORT # 2027111-2021-00600. THE TROCAR WAS PLACED IN THE PATIENT AND DURING INSTRUMENT EXCHANGE THE CLEAR PLASTIC FROM THE SEAL WAS PUSHED DOWN THROUGH THE TROCAR AND INTO THE PATIENT ABDOMEN. THE SURGICAL TEAM NOTICED THE PIECE ON THE MONITOR AND RETRIEVED IT FROM THE PATIENT. IT IS UNKNOWN WHICH INSTRUMENTS WERE USED AT THE TIME OF THE EVENT. THE COMPLAINT TROCAR WAS REPLACED WITH A NEW TROCAR. THIS HAS OCCURRED A TOTAL OF TWO TIMES AT THIS FACILITY. NO PATIENT INJURY. PATIENT IS STABLE AND HAS BEEN DISCHARGED. PRODUCT IS NOT AVAILABLE FOR RETURN. UNIT WAS DISPOSED OF BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 04AUG2021 FROM USER FACILITY: FOR BOTH CASES THE ENTIRE CLEAR PLASTIC COMPONENT FELL INTO THE PATIENT. THE COMPONENT FELL INTO THE PATIENT DURING THE MANIPULATION OF THE INSTRUMENTS. DURING ONE OF THE CASES, IT OCCURRED DURING THE MANIPULATION OF A MARYLAND GRASPERS. IT IS UNKNOWN WHICH INSTRUMENT WAS BEING USED DURING THE OTHER EVENT. NO PHOTOS ARE AVAILABLE OF THE PRODUCTS. TYPE OF INTERVENTION: THE CLEAR INSERT WAS RETRIEVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297237 ↗
• MalfunctionAug 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC TOTAL HYSTERECTOMY. EVENT DESCRIPTION: EVENT 1 OF 2: REPORT #2027111-2021-00599. EVENT 2 OF 2: REPORT # 2027111-2021-00600. THE TROCAR WAS PLACED IN THE PATIENT AND DURING INSTRUMENT EXCHANGE THE CLEAR PLASTIC FROM THE SEAL WAS PUSHED DOWN THROUGH THE TROCAR AND INTO THE PATIENT ABDOMEN. THE SURGICAL TEAM NOTICED THE PIECE ON THE MONITOR AND RETRIEVED IT FROM THE PATIENT. IT IS UNKNOWN WHICH INSTRUMENTS WERE USED AT THE TIME OF THE EVENT. THE COMPLAINT TROCAR WAS REPLACED WITH A NEW TROCAR. THIS HAS OCCURRED A TOTAL OF TWO TIMES AT THIS FACILITY. NO PATIENT INJURY. PATIENT IS STABLE AND HAS BEEN DISCHARGED. PRODUCT IS NOT AVAILABLE FOR RETURN. UNIT WAS DISPOSED OF BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON (B)(6) 2021 FROM USER FACILITY: FOR BOTH CASES THE ENTIRE CLEAR PLASTIC COMPONENT FELL INTO THE PATIENT. THE COMPONENT FELL INTO THE PATIENT DURING THE MANIPULATION OF THE INSTRUMENTS. DURING ONE OF THE CASES, IT OCCURRED DURING THE MANIPULATION OF A MARYLAND GRASPERS. IT IS UNKNOWN WHICH INSTRUMENT WAS BEING USED DURING THE OTHER EVENT. NO PHOTOS ARE AVAILABLE OF THE PRODUCTS. TYPE OF INTERVENTION: THE CLEAR INSERT WAS RETRIEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297234 ↗
• MalfunctionMar 6, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM [NAME]. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: OCTOBER 17, 2018. 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 A NEW DEFECT. WE WOULD LIKE YOU TO INVESTIGATE THE CAUSE OF THIS ISSUE AND WOULD LIKE YOU TO HAVE CORRECTIVE ACTION FOR FOLLOWING DEFECTS. (1) INSUFFICIENT HEAT SEAL (FOREIGN OBJECT IN THE HEAT SEAL). PATIENT STATUS: NA. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9803080 ↗
• MalfunctionJul 18, 2018Leak/Splash; Leak/Splash

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE BALLOON FAILED TO INFLATE. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. LIMITED INFORMATION IS AVAILABLE AT THIS TIME. THE PATIENT STATUS IS UNKNOWN. IT IS UNKNOWN IF THE BALLOON WAS TESTED PRIOR TO PLACING THE TROCAR INTO THE PATIENT. IT IS UNKNOWN IF ANY INSTRUMENTS CAME INTO CONTACT WITH THE BALLOON. THE DEVICE IS WITH THE RISK MANAGEMENT DEPARTMENT AT THE HOSPITAL AT THIS TIME. THE LOT NUMBER IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 15MAY2018 FROM ACCOUNT MANAGER: "BALLOON NEVER INFLATED" "NO DAMAGE AND NO RETRACTORS" ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 20JUN2018 FROM ACCOUNT MANAGER: "AFTER SPEAKING WITH THE ACCOUNT, THE BALLOON ON THE CFR03 WAS DAMAGED DUE TO THE SCRUB TECH PULLING THE RETENTION RING OFF THE CANNULA. DUE TO ERROR OF THEIR EMPLOYEE, THEY ARE NOT REQUESTING A RETURN ON THE PRODUCT." ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH #MW5077984 ON 9JUL2018: "FAILED TO INFLATE" ADDITIONAL INFORMATION RECEIVED VIA MAIL FROM RISK MANAGEMENT DEPARTMENT 16JUL2018: "YES, I BELIEVE THESE ARE FROM THE SAME INCIDENT REPORT. I HAVE IT IN MY POSSESSION IF YOU NEED TO SEE IT." PA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699808 ↗
• MalfunctionJul 24, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED - "UNKNOWN" "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." "REPORT FROM THE SALES REP: THE CUSTOMER HAD A RESERVATION ABOUT POTENTIAL FRAGMENTATION FROM 3 EVENT UNITS DURING A PROCEDURE. THE FRAGMENT WAS NOT RETURNED DUE TO AN INSPECTION IN OTHER MANUFACTURE'S PRODUCTS. INSTEAD, THE PICTURE WAS SENT TO US. ASIDE FORM 3 EVENT UNITS, ANY APPLIED MEDICAL DEVICES WERE NOT USED DURING A PROCEDURE. SOME CLIP APPLIERS AND TROCARS OF [COMPETITOR] WERE USED. INITIAL INVESTIGATION REPORT: THREE(3) EVENT UNITS WERE RETURNED TO US AND VISUALLY INSPECTED. INSTEAD OF THE WHITISH FRAGMENT(THE SIZE IS UNKNOWN), ITS PICTURE WAS SENT TO US. NO DAMAGE WAS OBSERVED WITH THE EVENT UNITS. THE BALLOONS WERE SUCCESSFULLY INFLATED TO PROVE THAT NO DAMAGE IS IN THE BALLOONS. PLEASE NOTE THAT SINCE WE RECEIVED THE CUSTOMER'S DEMAND TO PROMPTLY IDENTIFY SOURCE OF THE FRAGMENT, THE BALLOON INFLATION TESTS WERE SPECIALLY CONDUCTED TO PROVE THAT NO DAMAGE IS IN THE BALLOONS. THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4). REQUEST: PLEASE IDENTIFY WHETHER OR NOT THE FRAGMENT WAS FROM THE APPLIED MEDICAL TROCARS". ADDITION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737566 ↗
• MalfunctionMar 24, 2017Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED UNKNOWN- "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP: DURING A PROCEDURE, GRADUAL AIR LEAKAGE OCCURRED. THERE WAS NO ABRUPT LOSS OF PNEUMO AND VISIBILITY. INITIAL INVESTIGATION REPORT BY (B)(4): THE EVENT UNIT WAS RETURNED TO (B)(4) AND VISUALLY INSPECTED. THE OBTURATOR REMAINED INSERTED INTO THE TROCAR. NO DAMAGE WAS OBSERVED WITH THE DDB, THE SEPTUM AND SHIELD. NO FOREIGN MATERIAL WAS FOUND INSIDE THE STOPCOCK LEVER. THE DDB WAS IN THE STATE OF BEING EASILY REMOVED FROM THE SEAL. IT'S UNKNOWN IF THE CUSTOMER MADE THIS TO CHECK THE SEPTUM OR NOT. OLYMPUS COULD NOT IDENTIFY THIS CAUSED THE REPORTED INCIDENT. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." PATIENT STATUS: "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6434179 ↗
• MalfunctionMar 22, 2017Gas/Air Leak; Gas/Air Leak

  MYOMECTOMY - "THIS DEVICE IS AIR LEAKING ON KII SEAL." PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6426365 ↗
• 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 FOUND BLACK DEBRIS DROPPED OFF FROM CANNULA DURING AN OPERATION AND RECOVERED THE DEBRIS. NOTICING INSUFFLATION LEAKAGE AND REPLACED THE EVENT UNIT TO A DIFFERENT UNIT AND COMPLETED THE PROCEDURE. THERE WAS NO HEALTH DAMAGE TO PATIENT. (B)(4) OLYMPUS RECEIVED THE EVENT UNIT AND THE BLACK DEBRIS. ON EVALUATING THEM, WE CONFIRMED SEPTUM BREACH AND ALSO CONFIRMED THE DEBRIS WAS A PORTION OF THE SEPTUM. THE DEBRIS IS APPROXIMATELY 4.7MM BY 3.1MM. PLEASE ANALYZE THIS PHENOMENON AND REVIEW THE DEVICE HISTORY RECORDS OF THE EVENT UNIT." PATIENT STATUS: PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372809 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  "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 COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "A RUBBER FRAGMENT WAS FOUND INSIDE THE ABDOMINAL CAVITY DURING INTESTINAL LAVAGE. PROCEDURE: LAPAROSCOPIC COLECTOMY. COMBINED INSTRUMENTS: SONOSURG, GRASPER, DISSECTOR, SCISSORS, GAUZE. THE EVENT UNIT AND A BLACK FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SEPTUM HAD A MISSING PORTION OF APPROX. 1.4 MM X 1.7 MM AND THE FRAGMENT DID NOT MATCH THE PORTION IN SHAPE. THE FRAGMENT MEASURED APPROX. 3.5 MM X 5.1 MM AND WAS LARGER THAN THE MISSING PORTION, THUS IT IS LIKELY THE FRAGMENT WAS ORIGINATED FROM ANOTHER INSTRUMENT USED IN THE SAME PROCEDURE. (B)(4) OLYMPUS ATTEMPTED TO IDENTIFY THE SOURCE INSTRUMENT BUT COULD NOT OBTAIN ADDITIONAL INFORMATION. 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 6372498 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LATG - "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). A BLACK RUBBER FRAGMENT WAS FOUND IN THE ABDOMINAL CAVITY AFTER TRANSECTION OF ESOPHAGOGASTRIC JUNCTION. PROCEDURE: LATG. INSTRUMENTS USED IN THE PROCEDURE: ETHICON STAPLER POWERED ECHLON, OLYMPUS VIDEO-SCOPE ENDOEYE FLEX LTF-190-10-3D, FORCEPS, AND GAUZE. THE USER FACILITY RETURNED ALL TROCARS USED IN THE PROCEDURE AS THEY COULD NOT IDENTIFY THE SOURCE OF THE FRAGMENT. RETURNED TROCARS: C0R47 (1), CFR47 (2), AND CFR03 (2). THIS COMPLAINT SHEET IS FOR THE CFR03S. PLEASE REFER TO THE COMPLAINT SHEETS (B)(4) FOR THE OTHER TROCARS. TWO CFR03S WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED: NO DAMAGE WAS FOUND WITH BOTH UNITS. THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." PATIENT STATUS- "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370840 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LATG - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). A BLACK RUBBER FRAGMENT WAS FOUND IN THE ABDOMINAL CAVITY AFTER TRANSECTION OF ESOPHAGOGASTRIC JUNCTION. PROCEDURE: LATG. INSTRUMENTS USED IN THE PROCEDURE: ETHICON STAPLER POWERED ECHLON, OLYMPUS VIDEO-SCOPE ENDOEYE FLEX LTF-190-10-3D, FORCEPS, AND GAUZE. THE USER FACILITY RETURNED ALL TROCARS USED IN THE PROCEDURE AS THEY COULD NOT IDENTIFY THE SOURCE OF THE FRAGMENT. RETURNED TROCARS: C0R47 (1), CFR47 (2), AND CFR03 (2). THIS COMPLAINT SHEET IS FOR THE CFR03S. PLEASE REFER TO THE COMPLAINT SHEETS ADMIN#(B)(4) FOR THE OTHER TROCARS. TWO CFR03S WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED: NO DAMAGE WAS FOUND WITH BOTH UNITS. THE UNITS 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 6370839 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN: "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). TWO (2) OF THE DEFECT UNITS WILL BE RETURN TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. THE PHYSICIAN FOUND A FRAGMENT OF SEPTUM INSIDE THE PATIENT TOWARD THE END OF LADG USING MULTIPLE TROCARS. THE FRAGMENT WAS RETRIEVED IMMEDIATELY BUT THE MODEL NAME COULD NOT BE IDENTIFIED. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY. FIVE (5) OF THE EVENT UNITS BELOW WERE RETURNED TO OLYMPUS WITH A BLACK FRAGMENT OF SEPTUM: C0R47 (X1), CFR73 (X2), AND CFR03 (X2). UPON INSPECTION, NO VISUAL DAMAGE WAS FOUND ON BOTH OF THE CFR03S. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE UNITS. (B)(4)." COMBINE WITH (B)(4). PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370641 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). TWO (2) OF THE DEFECT UNITS WILL BE RETURN TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. THE PHYSICIAN FOUND A FRAGMENT OF SEPTUM INSIDE THE PATIENT TOWARD THE END OF LADG USING MULTIPLE TROCARS. THE FRAGMENT WAS RETRIEVED IMMEDIATELY BUT THE MODEL NAME COULD NOT BE IDENTIFIED. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY. FIVE (5) OF THE EVENT UNITS BELOW WERE RETURNED TO (B)(4) WITH A BLACK FRAGMENT OF SEPTUM: C0R47 (X1), CFR73 (X2), AND CFR03 (X2). UPON INSPECTION, NO VISUAL DAMAGE WAS FOUND ON BOTH OF THE CFR03S. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE UNITS. (B)(4)." COMBINE WITH (B)(4). PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370640 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  "THIS IS THE COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. A SEAL CAP CAME OFF FROM A SEAL AT THE MOMENT PHYSICIAN TAKE AN OBTURATOR OUT FROM THE SEAL DURING A PROCEDURE. AND THEN AIR LEAK CONFIRMED RIGHT AFTER THAT. PHYSICIAN CUT THE BALLOON AND TOOK OUT THE CANNULA. THE ACTUAL EVENT UNIT WAS RETURNED TO (B)(4) AND VISUALLY INSPECTED. A SEAL CAP CAME OFF FROM THE SEAL AND ALL OF THE COMPONENTS WERE SEPARATED FROM THE SEAL. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THIS UNIT. (B)(4)." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370437 ↗
• MalfunctionJan 3, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO PROCEDURE PERFORMED - "THE NURSE NOTICED A HOLE IN THE POUCH PACKAGING OF THE TROCAR." TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6220376 ↗