Kii® Optical Access System C0R83Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00607915116668), received between Jun 25, 2016 and Sep 15, 2022 — classified as 18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 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: JULY 22, 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 - C0R83 LOT#: 1425082 (1 EA.). PATIENT STATUS: (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432577 ↗
• MalfunctionJun 12, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION PO# 152P110. THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: APRIL 25, 2020. 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. POUCH TORN - C0R83 LOT# 1382988 (1 EA). PATIENT STATUS: NA. INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 10151151 ↗
• MalfunctionJan 5, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ESOPHAGECTOMY. EVENT DESCRIPTION: DURING AN ESOPHAGECTOMY THEY USED THESE 2 TROCARS AND THEY FOUND A LITTLE PEACE OF RUBBER IN THE THORAX. THE COLLECTED THE PEACE OF RUBBER. THE CUSTOMER WANTS TO KNOW IF THIS PEACE OF RUBBER CAME FROM THE SEALS OF 1 OF THE TROCARS OR WAS A PIECE OF RESIDUAL RUBBER FROM PRODUCTION. THERE WHERE NO PATIENT INJURIES OR COMPLICATIONS. ADDITIONAL INFO RECEIVED BY PHONE ON DECEMBER 11 FROM THE TM WHEN TAKING THE COMPLAINT THAT IT IS NOT KNOWN IF THE PIECE OF RUBBER IS FROM ONE OF THE TROCARS. TYPE OF INTERVENTION: N/A. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170473 ↗
• MalfunctionOct 6, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LIVER CANCER". EVENT DESCRIPTION: "DURING THE SURGERY, WHEN CO2 INSUFLATION STARTED, AIR LEAK WAS FOUND." TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6922375 ↗
• MalfunctionAug 31, 2017Break; Break

  PROCEDURE PERFORMED: "GASTRECTOMY". EVENT DESCRIPTION: "THE TIP OF THE TROCAR CANNULA WAS BROKEN WHEN THEY PULLED BACK THE RETRIEVAL BAG DURING SURGERY". ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) SALES MANAGER ON AUGUST 10, 2017 - THE CANNULA TIP SIMPLY PARTICULATED. ONE PIECE WAS CHIPPED OFF. IT WAS A NOTABLE SIZE PIECE FALLEN INTO THE PATIENT BODY. IT WAS RETRIEVED WITH NO SPECIAL INJURY. TYPE OF INTERVENTION: NA. PATIENT STATUS: "NO SPECIAL INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836262 ↗
• MalfunctionAug 21, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION : "GAS WAS LEAKED ON THE SEAL." TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807678 ↗
• MalfunctionApr 14, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "UNKNOWN (USED FOR PROCEDURE RELATED TO ESOPHAGUS)" INCIDENT DESCRIPTION: "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 TWO PETALS OF THE SHIELD FELL OFF INSIDE ABDOMINAL CAVITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THEM REMOVED FROM THE PATIENT USING A GRASPER. HE MENTIONED THE SHIELD WAS LIKELY CUT USING A SCISSORS. HE COMPLAINED THAT PARTS POTENTIALLY FALLING INSIDE ABDOMINAL CAVITY SHOULD NOT BE TRANSPARENT COLOR, IN THE LIGHT OF IDENTIFICATION. THE SEPTUM AND THE DDB WERE CUT FOR A CHECK INSIDE THE SEAL." INITIAL INVESTIGATION REPORT BY (B)(4): "THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. IT WAS NOTED THAT THE SEPTUM AND THE DDB WERE CUT FOR A CHECK INSIDE THE SEAL BY THE FACILITY. CONFIRMED THAT THE SHIELD WAS FRAGMENTED AND MISSING A PORTION. THE RETURNED PETALS ARE SIMILAR TO THE MISSING SITE OF THE SHIELD IN SHAPE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#(B)(4)." TYPE OF INTERVENTION: "THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THEM REMOVED FROM THE PATIENT USIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494209 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM SEAL OF THE DEVICE WAS FOUND TO BE TORN APART AND CAUSED CONSTANT LEAKAGE OF PNEUMOPERITONEUM. ONLY THE SEAL WAS RETURNED WITHOUT ITS OBTURATOR AND CANNULA." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372898 ↗
• MalfunctionMar 2, 2017Fluid/Blood Leak; Torn Material

  LAPAROSCOPIC GASTRECTOMY- "THE SEPTUM SEAL OF THE DEVICE WAS FOUND TO BE TORN APART AND CAUSED CONSTANT LEAKAGE OF PNEUMOPERITEUM." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372896 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPG - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). THE DEFECT UNIT ONLY WILL BE RETURNED TO AMR. NO FRAGMENT RETURNED. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. THE EVENT UNIT STARTED LEAKING AIR AFTER GAUZE WAS REMOVED FROM THE ABDOMINAL CAVITY DURING LAPG USING 5 MM FORCEPS. THE ACTUAL DEFECT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED: THE SEPTUM WAS FOUND TO HAVE A MISSING PART OF APPROX. 1.9 MM X 2.5 MM. NO FRAGMENT WAS SENT BY THE USER FACILITY. THE DEFECT UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. PLEASE INCLUDE THE CAUSE OF THE AIR LEAK IN THE CLOSING LETTER AND ADVISE US ON HOW TO PREVENT THIS TYPE OF INCIDENT. (B)(4)." PATIENT STATUS - "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370830 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370462 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370461 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370460 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370459 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370458 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY - "THE SEPTUM PART TEARS DURING THE SURGERY. ESPECIALLY, AFTER SURGEON USES COVIDIEN STAPLER." PATIENT STATUS: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370455 ↗
• MalfunctionJan 10, 2017Gas/Air Leak; Gas/Air Leak

  GASTRECTOMY - "CLIENT SET UP THIS DEVICE INTO PATIENT BODY AND THEN IT IS AIR LEAK." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR ON SEPTEMBER 7, 2016 THE USER DOES NOT KNOW WHICH INSTRUMENTS WERE INTRODUCED. THERE WAS AN INSTRUMENT AT THE TIME OF LEAKAGE, BUT WHEN THEY EXCHANGE THE OTHER C0R83 THAT IS NORMAL. THE INCISION SITE WAS NOT LARGER THAN NORMAL. PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6237370 ↗
• MalfunctionJun 25, 2016Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC GASTRECTOMY: "THE LAYERS IN THE TROCAR TEARING DUE TO THE STAPLER DURING PROCEDURES. CUSTOMER DIDN'T WANT TO HAVE OUR FEEDBACK. CER SUBMISSION HAS BEEN DELAYED BECAUSE (B)(6) SALES MANAGER CHANGED THEIR ACCOUNT. THE PRODUCT WAS REPLACED WITH (B)(6) STOCK." PATIENT STATUS - "THERE WAS NO PATIENT INJURY BECAUSE THEY CHANGE THE PRODUCT RIGHT AFTER THEY FOUND OUT DEFECT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749462 ↗