Kii® Balloon Blunt Tip System C0R50Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00607915116460), received between Feb 1, 2016 and Aug 29, 2023 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 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 #24016. THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: JULY 3,2023. 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 - C0R50 LOT #1477626 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643813 ↗
• MalfunctionJun 30, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  PROCEDURE PERFORMED. NA (INCOMING INSPECTION). EVENT DESCRIPTION: [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: MAY 19,2023. 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 - C0R50 LOT #1477627 (1 EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241169 ↗
• MalfunctionApr 24, 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: MARCH 10, 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: C0R50 LOT #1462088 (1 EA.).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16803089 ↗
• MalfunctionJan 10, 2023Contamination; Device Contaminated During Manufacture or Shipping; Contamination; 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: NOVEMBER 28,2022 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 - C0R50 LOT #1464958 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131205 ↗
• MalfunctionJul 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: [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: JUNE 3, 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 - C0R50 LOT #1442168 (1 EA). PATIENT STATUS: NA(NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126859 ↗
• MalfunctionDec 21, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. PROCEDURE PERFORMED: [TRANSLATION]: BALLOON DOES NOT INFLATE. WE TOOK A NEW TROCAR. BEGINNING OF INTERVENTION NO CLINICAL CONSEQUENCES ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2021: NAME OF PROCEDURE BEING PERFORMED: CHOLECYSTECTOMY. DATE OF INCIDENT: (B)(6) 2021. THE BALLOON MALFUNCTION WAS NOTICED BEFORE USE. THERE WAS NO DAMAGE TO THE BALLOON OR THE BALLOON INFLATION PORT. THIS WAS NOT A ROBOTIC CASE. METAL RETRACTORS WERE USED. NO SHARP INSTRUMENT COME INTO CONTACT WITH THE BALLOON. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052503 ↗
• MalfunctionJul 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA . EVENT DESCRIPTION: [NAME] INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [NAME]. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: MAY 31, 2021. 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 - C0R50 LOT# 1412557 (1 EA). TYPE OF INTERVENTION: NA. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220974 ↗
• MalfunctionJan 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: "REPORT FROM THE SALES REP: THE FOREIGN MATERIAL WAS FOUND WHEN THE BALLOON WAS INJECTED THE AIR. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. WE CONFIRMED THE BRAWN FOREIGN MATERIAL LIKE A TISSUE ON THE PROXIMAL SIDE OF THE BALLOON (PIC.1). THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11226821 ↗
• MalfunctionNov 12, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "ROBOTIC PROCEDURES." EVENT DESCRIPTION: MEDWATCH RECEIVED VIA MAIL ON 02NOV2020. MEDWATCH UF/IMPORTER REPORT #(B)(4). THE EVENT DATE IS UNKNOWN. THE EVENT OCCURRED IN (B)(6) 2020. "TROCAR BROKE DURING SURGERY. A RUBBERY PIECE OF THE TIME BROKE OFF AND FELL INTO THE PATIENT. THE PIECES WERE ABLE TO BE RETRIEVED." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19NOV2020 FROM USER FACILITY: THE DEVICE WAS USED IN ROBOTIC PROCEDURES. THE CASE WAS COMPLETED WITH A NEW TROCAR. IT IS BELIEVED THE TROCAR WAS USED AS A CAMERA PORT. A PIECE OF THE SEAL FELL INTO THE PATIENT BUT IT WAS RETRIEVED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE DEVICE IS NOT AVAILABLE FOR RETURN. INTERVENTION: "GOT NEW TROCAR." PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10833250 ↗
• MalfunctionNov 4, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOT ASSISTED LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: MEDWATCH REPORT #(B)(4) RECEIVED VIA MAIL ON 26OCT2020: "WHILE PERFORMING A ROBOT ASSISTED LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR MALFUNCTIONED. DURING THE PROCEDURE, INSUFFLATION OF THE ABDOMEN WAS LOST. STAFF DISCOVERED THE PLASTIC HASSAN TROCAR HAD BROKEN. THE TROCAR WAS REPLACED AND INSUFFLATION OF THE ABDOMEN AS OBTAINED.". ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28OCT2020 FROM USER FACILITY: THE EVENT DATE WAS (B)(6) 2020. THE LOCATION OF THE BREAK WAS "HASSAN". THE FRACTURE OCCURRED "AFTER INSUFFLATION, UNKNOWN REASON". NO PIECES FELL INTO THE PATIENT. THE FRACTURE DID NOT CAUSE PARTICULATION. ALL PIECES WERE RETRIEVED. THE PORT WAS NOT USED WITH A ROBOT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29OCT2020 FROM USER FACILITY: "THE TROCHAR BROKE AND WAS REMOVED. NO PIECES FELL INTO THE PATIENT.". ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 03DEC2020 FROM USER FACILITY: "WE WILL NOT BE RELEASING THIS PRODUCT AT THIS TIME. I HAVE BEEN ADVISED BY MY PATIENT SAFETY OFFICER TO HOLD ON TO THIS PRODUCT LONGER.". TYPE OF INTERVENTION: THE TROCAR WAS REPLACED AND INSUFFLATION OF THE ABDOMEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10788159 ↗
• MalfunctionSep 3, 2020Material Fragmentation; Material Fragmentation

  EVENT 1 OF 2: MEDWATCH # 2027111 - 2020 - 00528. EVENT 2 OF 2: MEDWATCH # 2027111 - 2020 - 00549. PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: "THE BALLOON TIP BROKE OFF WHEN INSERTING INTO THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 04AUG2020 FROM HOSPITAL MATERIALS MANAGEMENT: THE REPORT WAS FILED WITHIN THE FACILITY ON 03AUG2020. THE EVENT DATE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04SEP2020 FROM HOSPITAL RN: THE BALLOON ON THE TROCAR LEAKED DURING THE CASE. IT WAS A SLOW LEAK AND NO PIECES WERE LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER C0R50 TROCAR. THE PATIENT STATUS WAS FINE. THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH ANOTHER C0R50 TROCAR. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491722 ↗
• MalfunctionAug 12, 2020Material Fragmentation; Material Fragmentation

  EVENT 1 OF 2: MEDWATCH # 2027111 - 2020 - 00528. EVENT 2 OF 2: MEDWATCH # 2027111 - 2020 - 00549. PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: "THE BALLOON TIP BROKE OFF WHEN INSERTING INTO THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 04AUG2020 FROM HOSPITAL MATERIALS MANAGEMENT: THE REPORT WAS FILED WITHIN THE FACILITY ON 03AUG2020. THE EVENT DATE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04SEP2020 FROM HOSPITAL RN: THE BALLOON ON THE TROCAR LEAKED DURING THE CASE. IT WAS A SLOW LEAK AND NO PIECES WERE LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER C0R50 TROCAR. THE PATIENT STATUS WAS FINE. THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH ANOTHER C0R50 TROCAR. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10397597 ↗
• MalfunctionJul 10, 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# (B)(4). THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: MAY 27, 2020. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECT AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURN THE PRODUCT. POUCH TORN - C0R50 LOT# 1383014 (1 EA.). PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 10258598 ↗
• MalfunctionDec 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: NOVEMBER 18, 2019. PLEASE REFER TO THE ATTACHMENT FILE. PER 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.". "I) WE FOUND THE TWO RECURRENCE DEFECTS. 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 SEALING". PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9468907 ↗
• MalfunctionJul 15, 2019Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LEFT INFERIOR LOBECTOMY PROCEDURE WITH ROBOT. EVENT DESCRIPTION: THE OPERATING ROOM REPORTED A C0R50 TROCAR THAT BROKE DURING A LEFT INFERIOR LOBECTOMY PROCEDURE WITH ROBOT. THE END BROKE DURING THE PASSAGE OF THE ROBOT CAMERA. A PIECE OF PLASTIC FELL IN THE CHEST. IT HAS BEEN REMOVED. ORIGINAL: LE BLOC OPÉRATOIRE NOUS A RAPPORTÉ UN TROCART C0R50 QUI A CASSÉ LORS D'UNE INTERVENTION DE LOBECTOMIE INFÉRIEURE GAUCHE AU ROBOT. L'EXTRÉMITÉ A CASSÉ LORS DU PASSAGE DE LA CAMÉRA ROBOT. UN MORCEAU DE PLASTIQUE EST TOMBÉ DANS LE THORAX. IL A ÉTÉ RETIRÉ. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 1JULY19 IT WAS NOT A PART OF THE SEAL BUT A PART OF THE DISTAL TIP OF THE CANNULA. IT SEEMS THAT IT WAS TORN OFF. INTERVENTION: IT HAS BEEN REMOVED. PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791732 ↗
• MalfunctionFeb 22, 2019Material Puncture/Hole; Material Puncture/Hole

  PROCEDURE PERFORMED: ROBOT ASSISTED HYSTERECTOMY, BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: MEDWATCH REPORT # (B)(4) RECEIVED VIA MAIL ON 06FEB2019. DATE OF EVENT: (B)(6) 2018. "AIR SEAL DETECTED. HOLE FOUND IN BALLOON." DEVICE AVAILABLE FOR RETURN. "DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING);" OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: "NONE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8364434 ↗
• MalfunctionMar 27, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UPPER GS SURGERY LAPAROSCOPIC ROBOTIC ESOPHAGECTOMY. EVENT DESCRIPTION: "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." "SHIELD FELL OFF" "REPORT FROM THE SALES REP: THE ESOPHAGECTOMY WAS PERFORMED WITH DA VINCI SYSTEM (VERSION:SI). DURING AN INSERTION OF AN ENDOSCOPE FOR DA VINCI SYSTEM, ONE OF THE SEAL COMPONENTS, THE TRANSPARENT VALVE WAS REMOVED AND IT FELL OFF INSIDE THE ABDOMEN. ALL PIECES WERE RETRIEVED AND ARE ACCOUNTED FOR. THE PATIENT STATUS IS OK. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SHIELD WAS REMOVED FROM THE SEAL. HOWEVER, THE DDB AND SEPTUM REMAIN ASSEMBLED WITH THE SEAL. A PETAL OF THE SHIELD WAS FRAGMENTED FROM THE SHIELD. WE NOTED THE SEPTUM WAS FRAGMENTED. HOWEVER, THE FRAGMENT FOR THE MISSING SECTION ON THE SEPTUM WAS NOT RETURNED TO US. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4)" CER CHECK LIST OPERATION TIME WAS APPROXIMATELY 5 HOURS. THE SURGEON'S SKILL LEVEL WAS "ATTENDING/SKILLED SURGEON". MAIN USAGE OF THE DAMAGED TROCAR WAS THE CAMERA PORT. THE NUMBER OF INSERTION/REMOVAL DURING SURG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7376141 ↗
• MalfunctionDec 11, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "DA VINCI SI TAP INGUINAL HERNIA." EVENT DESCRIPTION: NO INCIDENT DESCRIPTION WAS INITIALLY PROVIDED FOR THE EVENT. INFORMATION WAS RECEIVED VIA EMAIL FROM TERRITORY MANAGER ON MONDAY 04 DEC 2017: "THE PATIENT WAS DISCHARGED WITH NO INJURY. I HAVE NOT BEEN ABLE TO GET ANY FURTHER DETAILS OTHER THAN IT WAS USED AS THE CAMERA PORT FOR THE DR VINCI." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM TERRITORY MANAGER ON TUESDAY 05 DEC 2017: "PER THE CUSTOMER, THEY WERE RUNNING THE 8.5 MM DAVINCI CAMERA THROUGH THE TROCAR AND PIECE OF THE BLACK SEAL BROKE OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE IT." TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: "THE PATIENT WAS DISCHARGED WITH NO INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105462 ↗
• MalfunctionOct 5, 2017Break; Break

  PROCEDURE PERFORMED: "DIAGNOSTIC LAPAROSCOPIC DAVINCI SURGERY." EVENT DESCRIPTION; "SURGEON PUT DAVINCI CAMERA DOWN THE HASSON TROCAR, AND THEN PLACED THE DAVINCI TROCAR IN THE BODY. WHEN THE SURGEON ANGLED THE SCISSORS OVER, THE METAL HIT THE PLASTIC TROCAR AND BROKE PART OF THE TIP OFF THE BOTTOM OF THE TROCAR. THEY WERE ABLE TO RETRIEVE THE PIECES. THEY HAD TO SWITCH TO OPEN SURGERY IN ORDER TO RETRIEVE THE PIECES." TYPE OF INTERVENTION: "THEY HAD TO SWITCH TO OPEN." PATIENT STATUS: "PATIENT WAS FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916491 ↗
• MalfunctionOct 4, 2017Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: DURING PROSTATECTOMY ROBOT, IMPOSSIBLE TO PUT THE OPTIC IN THE TROCAR OPEN AFTER HAVING CLEANED IT... DIFFICULT TO PREVENT THIS RISK WITHOUT USING THE TROCAR. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP VIA EMAIL ON 7 SEP 2017 AT 6:23 PM THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THE HOSPITAL HAS DISCARDED THE UNIT. THE PROSTATECTOMY UNDER LAPARO ROBOT ASSISTED WAS CARRIED OUT BY DR [NAME] , UROLOGIST AT THE CLINIC (B)(6). DURING THE OPERATION, THE OPTICS WAS REMOVED FROM THE OPEN TROCAR, REFERENCE C0R50 IN ORDER TO BE CLEANED, BUT WHEN IT WAS NECESSARY TO PUT IT BACK IN THIS TROCAR, IT WAS IMPOSSIBLE. ANOTHER TROCAR C0R50 HAS BEEN INSTALLED. THE OPTIC WAS NOT ABLE TO PASS THROUGH THE SEAL. TYPE OF INTERVENTION: CHANGE THE TROCAR. PATIENT STATUS: NO IMPACT ON THE PATIENT HEALTH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6914376 ↗
• MalfunctionSep 21, 2017Break; Break

  PROCEDURE PERFORMED: "ROBOTIC-ASSIST LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR WITH MESH, UMBILICAL HERNIA" EVENT DESCRIPTION: THIS REPORT WAS RECEIVED VIA MAIL FROM THE FDA MEDWATCH # MW5071472. "DURING PROCEDURE, INSTRUMENT TIP BROKE OFF - NOT RETAINED, PHYSICIAN ABLE TO RETRIEVE. NO HARM TO PT." TYPE OF INTERVENTION: "PHYSICIAN ABLE TO RETRIEVE" PATIENT STATUS: "NOT HARM TO PT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884353 ↗
• MalfunctionSep 21, 2017Break; Break

  PROCEDURE PERFORMED: "ROBOTIC-ASSIST BILATERAL INGUINAL HERNIA REPAIR WITH MESH, RIGHT ISCHIAL BONE BIOPSY" EVENT DESCRIPTION: THIS REPORT WAS RECEIVED VIA MAIL FROM THE FDA MEDWATCH # MW5071471. "DURING PROCEDURE INSTRUMENT TIP BROKE OFF DEVICE. RETRIEVED AND NO HARM TO PT." TYPE OF INTERVENTION: RETRIEVED PATIENT STATUS: NO HARM TO PT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884330 ↗
• MalfunctionJul 13, 2017Break; Break

  PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: MDR REPORT NUMBER (B)(4): EDGE OF KII BALLOON BLUNT TIP SYSTEM BROKE OFF DURING SURGERY. TYPE OF INTERVENTION: NA. PATIENT STATUS: UNK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6712905 ↗
• MalfunctionJul 5, 2017Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED ON 18JUL2017 FROM DISTRIBUTOR VIA EMAIL: "REGARDING INFORMATION ABOUT THE CONTACTED DEVICES, THE INFORMATION IS UNAVAILABLE. HOWEVER, IT WAS LIKELY THAT THE SECOND TROCAR CONTACTED A CERTAIN ENERGY DEVICE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6686748 ↗
• MalfunctionMay 26, 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 CUSTOMER NOTED THAT THE DDB WAS PARTIALLY DAMAGED AND A PORTION(APPROX. 1CM SQUARE) OF THE DDB WAS ATTACHED TO BE INSIDE THE SEAL. THE CUSTOMER GUESSED THAT INSERTION OF INSTRUMENTS CAUSED THE INCIDENT. SEPTUM CER CHECK LIST IS UNAVAILABLE." INITIAL INVESTIGATION REPORT BY (B)(4): "THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE REPORTED DAMAGE TO THE DDB WAS CONFIRMED; THE DDB WAS MISSING A PORTION; THE MISSING SIZE IS APPROX. 8.1 MM X 6.9 MM. ANY PORTIONS OF THE DDB WERE NOT SENT TO OLYMPUS. NO DAMAGE WAS OBSERVED WITH THE SEPTUM AND SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#(B)(4)." APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR VIA EMAIL ON MAY 8,2017: THE SECTION OF THE DOUBLE DUCKBILL DID NOT FALL INTO THE PATIENT IT STAYED IT STAYED WITHIN THE SEAL HOUSING. THE DISTRIBUTOR DID NOT KNOW WHAT INSTRUMENTS WERE USED IN THIS PORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596121 ↗