Kii® Optical Access System CTR03Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00607915123482), received between Apr 15, 2016 and Apr 24, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: WE USE YOUR LAPAROSCOPIC TROCARS. A CTR03 WAS BEING USED ON AN CASE AND THE SLEEVE BENT/TROCAR SNAPPED IN HALF. LOT: 1573129 EXP:2028-12-16. ALL PIECES RETRIEVED. NO HARM TO PATIENT. I HAVE THE FAULTY TROCAR. I LOOK FORWARD TO HEARING FROM YOU. ADDITIONAL INFORMATION PROVIDED BY [USER FACILITY REPRESENTATIVE] ON 14APR2026: I HAVE THE TROCAR AND ORIGINAL PACKAGE FOR RETURN. BEND/BREAK OCCURRED AT SHAFT. THE BEND/BREAK WAS IDENTIFIED DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. YES, THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT PICTURE PROVIDED. ADDITIONAL INFORMATION PROVIDED BY [USER FACILITY REPRESENTATIVE] ON 16APR2026: THE TROCAR WAS THE 3RD TROCAR OF THE CASE. THE 1ST 2 WENT IN WITHOUT ISSUES. THE SCRUB DID NOT NOTICE ANY UNUSUAL BEHAVIOR PRIOR TO THE TROCAR JUST SNAPPING. INTERVENTION: THEY REMOVED THE BROKEN PART AND USED A DIFFERENT TROCAR AND SLEEVE. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990233 ↗
• MalfunctionJan 14, 2026Fracture

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION: "THE OPTURATOR WAS BROKEN." PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068193 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  PROCEDURE PERFORMED: HEPATECTOMY. EVENT DESCRIPTION: THE OBTURATOR WAS ALREADY BROKEN, SO THEY COULDN'T USE IT. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469201 ↗
• InjuryJun 9, 2025Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: INSUFFLATION TUBING WAS HOOKED UP TO 5MM APPLIED MEDICAL PORT. SCOPE WAS DOWN A 12MM APPLIED MEDICAL PORT. AFTER LOSING INSUFFLATION, DOCTOR ADDED AN ADDITIONAL 12MM [NON-APPLIED MEDICAL] TROCAR AND INSUFFLATION WAS RESTORED, VESSEL CLIPPED AND BLEEDING UNDER CONTROL. WHEN THE INSTRUMENTS ARE IN THE NEW SIZE 5 APPLIED MEDICAL TROCARS AND YOU MOVE INSTURMENTS AROUND, YOU ARE BREAKING THE SEAL AND INHERENTLY LOSING INSUFFLATION. INSUFFLATION WAS LOST TOO QUICKLY AND THE NEW TROCARS DO NOT RE-INSUFFLATE FAST ENOUGH. DOCTOR WAS UNABLE TO APPLY CLIPS DUE TO LACK OF INSUFFLATION, CAUSING PROLONGED BLEEDING WHILE THE DOCTOR INSERTED AN ADDITIONAL 12MM PORT. DR. HAD TO PUT IN AN ADDITIONAL 12MM PORT AND SWITCH THE INSUFFLATION TUBING TO ONE OF THE TWO 12MM TROCAR PORTS. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 28MAY2025: THE PATIENT WAS STABLE AND RECOVERING WELL IN POST-OP. 450ML BLOOD LOSS, SURGICELL WAS USED TO STOP THE BLEEDING. THE DOCTOR REPORTED 100ML BLOOD LOSS IS EXPECTED FOR HIS TYPICAL LAP. CHOLES. INSUFFLATION LOSS WAS NOTED VERY EARLY IN THE CASE WHEN THE ASSIST NOTICED LACK OF FLOW

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22171178 ↗
• 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 14OCT24: 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 14OCT24: 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 15OCT24: 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. FIRST, H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510522 ↗
• MalfunctionAug 31, 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)(6). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: APRIL 7,2023. 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 - CTR03 LOT #1477583 (1 EA). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664621 ↗
• MalfunctionAug 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 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 - CTR03 LOT #1490660 (1 EA.). PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515256 ↗
• MalfunctionApr 25, 2023Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: TROCAR OBTURATOR FELL APART AS IT WAS IN THE PATIENT, CREATING A NEAR MISS. DEVICE WAS NOT USED AND A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 24APR2023 VIA EMAIL FROM USER FACILITY: THE CLEAR PLASTIC PORTION OF THE OBTURATOR SEPARATED FROM THE LOCKING CAP. ONE CANNULA WAS INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. THE BREAK WAS NOT CONSIDERED TO BE A CLEAN BREAK, THERE WAS A JAGGED SMALL PIECE. THE PIECE FELL INTO THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS ROBOTIC. INTERVENTION: A NEW DEVICE WAS USED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809165 ↗
• MalfunctionJan 9, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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: NOVEMBER 11,2022. 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 - CTR03 LOT #1462080 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122329 ↗
• MalfunctionNov 9, 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 (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: (B)(6), 2022. 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 AN INVESTIGATION. HAIRLIKE OBJECT IN POUCH: CTR03 LOT #1460640 (1 EA.) PRODUCT AVAILABLE FOR RETURN. TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763928 ↗
• MalfunctionJun 6, 2022Material Twisted/Bent; Material Twisted/Bent

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHILE INTRODUCING TROCAR INTO PATIENTS ABDOMINAL WALL TROCAR BENT WHILE APPLYING EXPECTED PRESSURE TO TROCAR & OBTURATOR, REACHED PATIENT BUT NO INJURY PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606853 ↗
• MalfunctionAug 2, 2018Material Fragmentation; Material Fragmentation

  PRODUCT PROCEDURE: UNKNOWN. EVENT DESCRIPTION: "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. CANNULA TIP FRAGMENTATION. REPORT FROM THE SALES REP. THE CUSTOMER NOTED AT THE END OF THE SURGERY, THE CANNULA TIP WAS FRAGMENTED INSIDE THE ABDOMINAL CAVITY. THE FRAGMENT WAS REMOVED FROM PATIENT, BUT IT IS POSSIBLE THAT ALL PIECES ARE NOT ACCOUNTED FOR. DURING INTRAPERITONEAL IRRIGATION, ANY FRAGMENTS WERE NOT CONFIRMED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT REPLACING THE EVENT UNIT. THE CUSTOMER RECOGNIZED HEAT OR FORCE FROM AN INSTRUMENT WAS APPLIED TO THE CANNULA TIP. PLEASE DETERMINE THE ROOT CAUSE AND WHICH THE CANNULA TIP DAMAGE CAME FROM HEAT OR FORCE FROM AN INSTRUMENT. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE CANNULA TIP WAS FRAGMENTED AND MELTED(PIC.1). THE RETURNED FRAGMENT(PIC.2) IS SIMILAR TO THE MISSING SECTION ON THE CANNULA IN SHAPE(PIC.3).THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4). ONE SEAL, CANNULA, FRAGMENT RETURNING. PLEASE SEE COMPONENT LIST." TYPE OF INTERVENTION: THE FRAGMENT WAS REMOVED FROM PATIENT. THE SURGERY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743154 ↗
• MalfunctionFeb 5, 2018Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: "LAPAROSCOPIC HERNIA REPAIR(TAPP OR TEP)" EVENT DESCRIPTION: " THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SHIELD REMOVED. REPORT FROM THE SALES REP. LAPAROSCOPIC HERNIA REPAIR(TAPP OR TEP) WAS PERFORMED. DURING REMOVAL OF A HERNIA TACKER(MANUFACTURER: UNKNOWN), THE CUSTOMER FELT STRONG RESISTANCE AND A TRANSPARENT COMPONENT BROKE OFF INSIDE ABDOMEN. THE UNIT WAS CHANGED OUT TO NEW ONE AND THE CASE WAS SUCCESSFULLY COMPLETE. THE FRAGMENT WAS REMOVED FROM PATIENT. NO PATIENT INJURY. INITIAL INVESTIGATION REPORT. THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SHIELD WAS REMOVED FROM THE SEAL, BUT NOT FRAGMENTED. NO DAMAGE WAS OBSERVED WITH THE DDB AND THE SEPTUM. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." TYPE OF INTERVENTION: "THE UNIT WAS CHANGED OUT TO NEW ONE AND THE CASE WAS SUCCESSFULLY COMPLETE." PATIENT STATUS: "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242967 ↗
• MalfunctionNov 14, 2017Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: UPON INITIAL PLACEMENT OF THE FIRST TROCAR INTO THE UMBILICUS, THE TROCAR SNAPPED WHILE PUSHING IT THROUGH. A PIECE OF THE TROCAR WAS IN THE PATIENT'S SKIN PART WAY AND THE DOCTOR USED A [NON-APPLIED] CLAMP TO PULL IT OUT. NO PIECES FELL INTO THE PATIENT. THE BREAK IS CONSIDERED A CLEAN BREAK. THE DOCTOR REPLACED THE TROCAR WITH [COMPETITOR] TROCAR AND COMPLETED THE REMAINDER OF THE CASE. NO PATIENT INJURY. THE DOCTOR IS A NEWER USER OF THE APPLIED TROCARS. THE SURGEON WAS ABLE TO USE OTHER APPLIED TROCARS IN SUBSEQUENT CASES, THE SAME DAY, WITHOUT INCIDENT. THE DEVICE IS AVAILABLE FOR RETURN. THE FACILITY FORWARDED A PHOTOGRAPH OF THE DEVICE TO THE IMPLEMENTATION SPECIALIST. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29-OCT-2017 AT 10:12 AM FROM CHARGE NURSE AT (B)(6): IT IS NOT VERIFIED THAT THE DOCTOR IS A NEWER USER OF APPLIED TROCARS. THE FACILITY WAS ON AN APPLIED TROCAR EVALUATION STARTING 19-SEP-2017. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 31-OCT-2017 AT 9:01 AM FROM IMPLEMENTATION SPECIALIST: PHOTOGRAPH PROVIDED OF THE BROKEN CANNULA. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7028312 ↗
• MalfunctionOct 18, 2017Break; Break

  PROCEDURE PERFORMED: LAR. EVENT DESCRIPTION: "WHEN THE NURSE OPENED THE PACKAGE, THE TROCAR WAS ALREADY BROKEN." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) SALES MANAGER ON AUGUST 10, 2017 : THE TIP OF THE CANNULA WAS ALREADY BROKEN BEFORE USE. THE DAMAGE WAS NOTICED AFTER UNPACKING. THERE WAS NO DAMAGE TO THE PRODUCT BOX OR THE POUCH. IT WAS NOTICED BEFORE THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM (B)(6) SALES MANAGER ON SEPTEMBER 07, 2017: "YES. I CONFIRM THAT THE CORRECT DEVICE, WHICH I RECEIVED THIS CER FROM MY DEALER WITH, WAS SENT. WE MADE CER REPORT, ACCORDING TO THEIR (B)(6) VERSION OF CER(BY SALES MANAGER) AND SENT IT WITH GIVEN RGA NUMBER (BY FINANCE MANAGER)." TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959550 ↗
• MalfunctionMar 2, 2017Break; Break

  UNKNOWN - "THIS IS THE COMPLAINT FROM THE MARKET. CANNULA, ATTACHED WITH OBTURATOR, BROKEN WHEN PHYSICIAN PUT THE UNIT INTO PATIENT BODY AFTER CUTTING PATIENT'S SKIN. AOMORI OLYMPUS CONFIRMED THE BROKEN CANNULA AND OBTURATOR. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE EVENT UNIT." PATIENT STATUS - THE PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372880 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  PARTIAL GASTRECTOMY - "BEFORE FINISH THIS SURGERY, DOCTOR CHECK AND WANT TO CLOSE THE WOUND THEN FOUND A VALVE DROP IN PATIENT BODY. DOCTOR MOVES THIS VALVE AND CHECKS THREE TROCARS THAT WERE NOT DAMAGE WITH VALVE. ATTACHMENT IS PHOTO WITH VALVE FOR YOU REFERENCE." PATIENT STATUS - FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370905 ↗
• MalfunctionOct 31, 2016Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  " THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." REPORT FROM THE SALES REP: "THE CUSTOMER FOUND THE DISTAL END OF THE CANNULA WAS MELTED. HE/SHE WAS UNFAMILIAR WHEN THE INCIDENT HAPPENED DURING A TREATMENT." INITIAL INVESTIGATION REPORT BY (B)(6): "THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. UPON VISUAL INSPECTION, THE DISTAL END OF THE CANNULA WAS FOUND TO BE PARTIALLY DAMAGED LIKE MELTED, HOWEVER, NOT CAUSING THE CANNULA TO BE FRACTURED. THE SEPTUM WAS FOUND TO BE TORN AND A PIECE OF THE SEPTUM (SIZE: APPROXIMATELY 3.3MM X 4.9MM) WAS FOUND INSIDE THE CANNULA BY THE SIDE OF THE SEAL. CONFIRMED THE PIECE WAS SIMILAR TO THE CUT SHAPE OF THE SEPTUM. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." REQUESTS: "THE CUSTOMER ACKNOWLEDGED THAT THE INCIDENT DIDN'T HAPPEN DUE TO AN ERROR IN MANUFACTURING PROCESS. HOWEVER, HE/SHE WOULD LIKE TO KNOW THE FOLLOWING POINT. PLEASE INCLUDE ANSWERS TO THIS QUESTION IN THE CLOSING LETTER. WHAT SITUATIONS ARE CONSIDERED TO ENCOUNTER THOSE KINDS OF THE INCIDENT THE CUSTOMER EXPERIENCED?"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6068450 ↗
• MalfunctionAug 11, 2016Fracture; Fracture

  PROCEDURE PERFORMED UNKNOWN- "REPORT FROM THE SALES REP - DURING A PROCESS TO DRAIN, WHILE PASSING A TUBE FROM THE EVENT UNIT TO ANOTHER TROCAR, THE DISTAL EDGE OF THE CANNULA WAS FRACTURED DESPITE GIVING NO EXCESSIVE POWER TO THE CANNULA. THE FRAGMENT OF THE CANNULA WAS DISPOSED BY THE FACILITY." ADDITIONAL INFORMATION RECEIVED JULY 19, 2016: THE INCIDENT HAPPENED AT THE END OF THE OPERATION, DURING INSTALLATION OF DRAINAGE PROCEDURE, WHILE PASSING A TUBE FROM THE EVENT UNIT TO ANOTHER TROCAR OR VICE VERSA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5870221 ↗
• MalfunctionApr 15, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  LAP CHOLE - "SURGEON WAS PERFORMING PROCEDURE AND NOTICED PLASTIC COILS THAT APPEARED TO COME FROM TROCAR." PATIENT STATUS - "DISCHARGED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5581511 ↗