Kii Fios First Entry CFF73Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00607915117658), received between Feb 6, 2016 and Jun 23, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (36 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC GALLBLADDER OPERATION. EVENT DESCRIPTION: [TRANSLATION] DURING A LAPAROSCOPIC GALLBLADDER OPERATION, A PART HAD COME LOOSE FROM THE TROCAR THAT SHOULD HAVE BEEN FIRMLY ATTACHED TO THE INSTRUMENT. THE ISSUE WAS NOTICED WHEN THE CO2 GAS DID NOT REMAIN IN THE ABDOMINAL CAVITY, AND AN INVESTIGATION INTO THE CAUSE WAS INITIATED. THE SURGEON NOTICED A BRIGHT PLASTIC PART THAT HAD COME LOOSE FROM THE TROCAR AND A SMALL BLACK PLASTIC FRAGMENT IN THE ABDOMINAL CAVITY. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12JUN26: THE USER RESOLVED THE SITUATION BY REPLACING WITH A NEW EQUIVALENT PRODUCT. INSTRUMENTATION USED AT THE TIME OF THE INCIDENT OR PRIOR TO THE INCIDENT NOT KNOWN. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. NOT KNOWN IF THE TRANSPARENT COMPONENT FELT ENTIRE OR PARTICULATE, BUT THE DEVICE WILL RETURN FOR EVALUATION. ALL THE PIECES REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15JUN26: BELOW IS A COMPLAINT REGARDING PRODUCT REF CFF73. THE PRODUCT CAN BE PICKED UP FROM THE CUSTOMER; DETAILS ARE PROVIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602548 ↗
• MalfunctionFeb 20, 2026Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SEGMENTECTOMY. EVENT DESCRIPTION: PART OF THE INTERNAL VALVE OF THE TROCART ABORD ABDO KII FIOS INSUFFLATION FASTENER 12 MM X 100 MM (CFF73) DETACHED DURING THE SEGMENTECTOMY PROCEDURE, LEADING TO RISK OF LEAVING A FOREIGN BODY IN THE PATIENT'S BODY AND EXCESSIVE USE OF EQUIPMENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REP VIA EMAIL ON 05FEB26: 1 NON-STERILE UNIT RETURNING. PATIENT STATUS: NO PATIENT INJURY NOR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403107 ↗
• MalfunctionDec 23, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: COLECTOMIE. EVENT DESCRIPTION: [TRANSLATION] DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON DISCOVERS A PLASTIC RING (TROCARS VALVE) AND A PIECE OF PLASTIC IN THE PATIENT'S ABDOMEN. NO DIRECT CONSEQUENCES: REMOVAL OF INTRA-ABDOMINAL ELEMENTS AND REPLACEMENT OF TROCARS. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE ON 08DEC25: PIECE OF PLASTIC IS REFERRING TO A PIECE OF THE OBTURATOR. ALL PIECES WERE RETRIEVED FROM THE PATIENT. HOSPITAL DOESN'T REMEMBER WHAT INSTRUMENTATION WAS BEING USED. IT WAS'T A ROBOTIC PROCEDURE. NO INTERNAL SEAL COMPONENTS REMOVED NOR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. INTERVENTION: DEVICE REPLACED. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885275 ↗
• MalfunctionDec 5, 2025Fracture; Fracture

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE HOSPITAL; THE TIP OF THE OBTURATOR WAS CRACKED. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. INTERVENTION: REPLACED WITH A HOSPITAL INVENTORY 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 23735319 ↗
• MalfunctionOct 28, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ENDOSCOPIC LEFT COLECTOMY. EVENT DESCRIPTION: REPORT FROM THE SALES REP. WHILE THE GAUZE WAS BEING INSERTED AND REMOVED WITH FORCEPS, THERE IS A SOUND AND THE PORT FELL APART. THE PART OF THIS UNIT WAS DROPPED IN THE BODY; HOWEVER, IT WAS TAKEN OUT AND THERE WAS NO IMPACT. THE PHOTO OF THIS EVENT UNIT IS NOT AVAILABLE SINCE IT HAS ALREADY SENT BACK FROM THE HOSPITAL. THIS UNIT WILL BE RETURNED. PRODUCT AVAILABLE FOR RETURN: 1 UNIT THE INVESTIGATION REPORT HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE ON 15OCT2025: THE PARTS FALLEN APART WERE BOTH OF KII SEAL AND CANULA. INTERVENTION: REPLACED WITH A NEW ONE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405764 ↗
• MalfunctionOct 24, 2025Crack; Fracture; Crack; Fracture

  PROCEDURE PERFORMED: COLECTOMY. EVENT DESCRIPTION: THE TIP OF THE TROCAR HAS CRACKED. NO FRAGMENTS WERE MISSING WHEN IT WAS REMOVED. PATIENT STATUS: THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379655 ↗
• MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP.CHOLECYSTECTOMY. EVENT DESCRIPTION: EVENT HAPPEN IN A CHOLECYSTECTOMY SURGERY. TIP FRACTURE ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 26AUG2025: IT WAS CONFIRMED THE OBTURATOR WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT AND A CAMERA WAS INSIDE. THIS WAS NOT A ROBOTIC CASE. INTERVENTION: DEVICE REPLACED. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919123 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC DISTAL PANCREATECTOMY. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE HOSPITAL. DURING TREATMENT, THE INNER SEAL FRAGMENT OF THE DUCKBILL FELL OUT THROUGH THE TROCAR INTO THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY CFF73 AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CFF73 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 22900381 ↗
• MalfunctionJun 19, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC COLECTOMY EVENT DESCRIPTION: THE DUCKBILL WAS DROPPED IN THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY CFF73 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL FIELD IMPLEMENTATION TEAM VIA EMAIL ON 05JUN2025: [TRANSLATION] IT IS A BLACK PART THAT APPEARS TO BE A COMPONENT OF C0R47. IT HAS BEEN ENCLOSED TOGETHER WITH THE TROCAR. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CFF73 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 22293415 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ANTERIOR RESECTION EVENT DESCRIPTION: PROCEDURE WAS COMING TO AN END AND THE TROCAR WAS REMOVED FROM THE ABDOMEN. THE SURGEONS WENT BACK INTO THE ABDOMEN THROUGH A DIFFERENT TROCAR TO HAVE A FINAL CHECK AND WASH OUT, A FRAGMENT OF THE SEPTUM FANNED INSTRUMENT GUIDE HAD APPEARED TO COME OFF THE TROCAR AND WAS INSIDE THE PATIENT. ALL FRAGMENTS WERE COLLECTED. UNSURE OF WHAT ACTION OR WHEN THE INCIDENT OCCURRED, THE INCIDENT WAS DISCOVERED AT THE END OF THE PROCEDURE. NO CLINICAL IMPACT TO IMPACT. THE TROCAR THAT HAS BEEN REPORTED IN THIS CER WAS USED THROUGHOUT THE CASE AS THE CAMERA/SCOPE TROCAR AND IT WAS NOT EXCHANGED OR REMOVED TILL THE END OF THE CASE. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VI EMAIL ON 15NOV24: NO IMAGES AVAILABLE AS THE SAMPLE WILL BE RETURNING. CONFIRMED WITH TM REGARDING WHAT PART OF THE SEAL CAME OFF AND TM CONFIRMED IT IS THE SHIELD THAT FRAGMENTED. NO SHARP INSTRUMENT WAS USED AND NO INTERNAL SEAL COMPONENTS WAS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VI EMAIL ON 18NOV24: TM CONFIRMED IT WAS A PIECE/PIEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201170 ↗
• MalfunctionDec 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPY CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING A LAP CHOLE SURGERY, THE SURGEON PUT A RAYTEX SPONGE THROUGH THE TROCAR AND INTO THE ABDOMEN TO HELP WITH HEMOSTASIS. WHILE UNDERWAY, THE SURGICAL ASSISTANT NOTICED THE TROCAR SEAL HAD DETACHED AND DROPPED INTO THE ABDOMEN. THEY WERE ABLE TO RETRIEVE THE PIECE SUCCESSFULLY WITH NO PATIENT INJURY. DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. APPLIED MEDICAL REPRESENTATIVE CURRENTLY CONFIRMING IT WAS A MODEL CFF73 OR CFS22. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 22NOV2024 VIA EMAIL : HE DOES NOT HAVE THE LOT NUMBER, SO HE SAID THAT A REPLACEMENT WILL BE FINE. HE¿S GOING TO PROVIDE ME WITH A NO CHARGE PO. HE IS NOW SAYING THAT HE HAS THE ITEM TO SEND BACK, BUT NOT THE PACKAGING IT CAME IN. CAN YOU PLEASE PROVIDE ME WITH A SHIPPING LABEL AS WELL AS A RGA LABEL AND I WILL GET THAT OVER TO HIM TO BEGIN THE PROCESS OF SENDING IT BACK. INTERVENTION: SEAL RETRIEVED FROM ABDOMEN. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931142 ↗
• MalfunctionNov 15, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: [NAME]L HOSPITAL. REPORT FROM THE SALES REP VIA EMAIL; UNOPENED PRODUCT WAS CHECKED AT [FACILITY] AND FOUND TO CONTAIN HAIR AND WAS NOT USED. THIS UNIT WILL BE RETURNED. PATIENT STATUS: NA - BEFORE USE. TYPE OF INTERVENTION: NA - BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699217 ↗
• MalfunctionJul 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: GYN PROCEDURE. DETAILED DESCRIPTION OF EVENT: WHEN OPENING, IT WAS NOTICED THAT THERE IS A HAIR/THREAD ON THE TROCAR IN THE PACKAGING. PRODUCT CAN BE COLLECTED. THIS MORNING WE GAVE A TROCAR 12MM REF CFF73 TO THE GYNAECOLOGIST. UNFORTUNATELY, THIS REVEALED THE FOLLOWING SIGHT. WE GAVE A SECOND TROCAR OF THE SAME BATCH AND EVERYTHING WAS FINE. TYPE OF INTERVENTION: USED A NEW TROCAR. PATIENT STATUS: NA - BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647661 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SUPERIOR COLON RESECTION: EVENT DESCRIPTION: WHEN GAUZE WAS INSERTED AND REMOVED DURING SURGERY VIA THE TROCAR IN QUESTION, A TRANSPARENT PART WAS FOUND TO BE MISSING FROM THE PRODUCT OUTSIDE THE BODY. THE PHYSICIAN HAS NO EXPERIENCE WITH SIMILAR INCIDENTS AND IS REQUESTING AN ANALYSIS OF THE CAUSE OF THE MALFUNCTION. THIS UNIT (SEAL&CANULA,OBTURATOR,SYRINGE) WILL BE RETURNED. INTERVENTION: REPLACED WITH CFF73 FROM HOSPITAL INVENTORY. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571090 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC S-SHAPED COLON RESECTION. EVENT DESCRIPTION: REPORT FROM THE SALES REP VIA EMAIL; THE PHYSICIAN REMOVED THE SEALING PART (HEAD) WHEN TRYING TO REMOVE THE SPECIMEN AND THE VALVE CAME OFF. THIS UNIT WILL NOT BE RETURNED. THE INVESTIGATION REPORT IS NOT REQUIRED. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 7MAY2024 VIA EMAIL: I ASKED THE AMJ FI TEAM TO CHECK WITH THE HOSPITAL. HOWEVER, THE ONLY RESPONSE WE RECEIVED WAS, "WE DON'T KNOW ABOUT THE CASE AT THAT TIME. INTERVENTION: REPLACED WITH A NEW CFF73. PATIENT STATUS: NO CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274517 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: THE REP WAS INFORMED VIA EMAIL OF AN EVENT INVOLVING A CFF73 TROCAR. ALL THAT IS KNOWN IS THAT THE TROCAR BROKE DURING THE SURGERY AND THAT THE FRAGMENTED PIECES WERE FOUND AND REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY. PRODUCT NOT AVAILABLE FOR RETURN ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2023 FROM ACCOUNT MANAGER, APPLIED MEDICAL: "PLASTIC SEAL FROM INSIDE THE TROCAR FELL OUT DURING INSERTION. THEN SOFT BLACK RUBBER PIECE FELL OFF AFTER INSERTION. I DO NOT KNOW HOW THE TROCAR WAS INSERTED, OR IF THERE WAS DIFFICULTY. THE TROCAR WAS USED TO COMPLETE THE CASE (IT WAS A ROBOTIC HYSTERECTOMY ). ALL PIECES WERE COLLECTED AND DISCARDED." INTERVENTION: FRAGMENTS WERE RECOVERED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039558 ↗
• MalfunctionOct 24, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOTIC SIGMOID COLECTOMY, FISTULA TAKEDOWN, ILEOSTOMY CREATION EVENT DESCRIPTION: THE KII BALLOON BLUNT TIP TROCAR WAS HIT BY A ROBOTIC ARM WITHIN THE ABDOMEN CAUSING THE TIP OF THE TROCAR TO BREAK OFF. NO ONE WAS HURT. THEY OPENED UP A NEW TROCAR AND INSERTED IT IN TO COMPLETE THE CASE. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 16OCT2023 FROM APPLIED MEDICAL, ACCOUNT MANAGER ASSOCIATE: A KII BALLOON BLUNT TIP TROCAR WAS USED DURING A ROBOTIC CASE AND MID-PROCEDURE THE TIP WAS BROKEN BY A SWINGING ROBOTIC ARM. ANOTHER TROCAR WAS USED TO FINISH THE CASE. THE TROCAR WAS SAVED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 18OCT2023 FROM APPLIED MEDICAL, ACCOUNT MANAGER ASSOCIATE: CFF73 LOT #1490705 BROKE DURING ROBOTIC SIGMOID COLECTOMY, FISTULA TAKEDOWN, ILEOSTOMY CREATION. ROBOTIC INSTRUMENT ARMS, (PROGRASP, SMALL GRASPING RETRACTOR, VESSEL SEALER) WERE BEING USED AT THE TIME OF THE EVENT. THE INTUITIVE SURGICAL /SIZE 8MM INSTRUMENT CLAMP WAS USED INT THE ROBOTIC SURGERY. THE CANNULA TIP BROKE INSIDE THE PATIENT ABDOMEN. THE OBTURATOR WAS NOT INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. THE BREAK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997185 ↗
• MalfunctionJan 5, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  PROCEDURE PERFORMED: GASTRECTOMY EVENT DESCRIPTION: REPORT FROM THE APPLIED MEDICAL REPRESENTATIVE: AFTER ABDOMINAL INSERTION, CO2 WAS INJECTED. THERE WAS AIR LEAK FROM THE CANNULA. THE DEVICE WAS REPLACED WITH THE NEW DEVICE. THERE WAS NO INSTRUMENT USED AT THE TIME OF THE INCIDENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02JAN2023 FROM THE APPLIED MEDICAL REPRESENTATIVE: IT IS DIFFICULT TO VERIFY EXACTLY WHERE THE BREAK OCCURRED. THE TROCAR WAS INSERTED WITHOUT ROTATION. THERE WAS NO DIFFICULTY DURING INSERTION. THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK, BUT IT IS DIFFICULT TO VERIFY THE DETAILS BECAUSE THE DEALER HAS THE EVENT UNIT NOW. THE BREAK DIDN'T CAUSE PARTICULATION. THE TROCAR WAS NOT USED WITH A ROBOT. THE IMAGE OF THE BROKEN CANNULA IS NOT AVAILABLE. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16105948 ↗
• MalfunctionNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOT ASSISTED HYSTERECTOMY. EVENT DESCRIPTION: THE TROCAR WAS BEING USED FOR A ROBOTIC ASSISTED HYSTERECTOMY. THERE WERE MULTIPLE LAPAROSCOPIC INSTRUMENT CHANGES DURING THE PROCEDURE. A CLEAR RING DETACHED FROM THE SEAL HOUSING AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE ENTIRE CLEAR COMPONENT FELL OUT. IT IS UNKNOWN WHAT SPECIFIC INSTRUMENTATION WAS BEING USED PRIOR AND AT THE TIME OF THE INCIDENT. THE REP WAS NOT PRESENT FOR THE CASE. IT IS UNKNOWN IF ANY INTERNAL SEAL COMPONENTS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. "THE SURGERY CONTINUED WITHOUT FURTHER INCIDENT." NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: THE SURGERY CONTINUED WITHOUT FURTHER INCIDENT. PATIENT STATUS: NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839118 ↗
• MalfunctionFeb 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# 154P055. THIS IS A COMPLAINT FROM AOMORI OLYMPUS EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: DECEMBER 17, 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. HAIRLIKE OBJECT IN POUCH - CFF73 LOT #1429114 (1 EA.). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539022 ↗
• MalfunctionJan 12, 2022Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED BY MAIL ON 03-JAN-2022. REPORT NUMBER MW5105036. THE BALLOON BROKE WHILE SURGEON WAS MANIPULATING THE TROCAR IN THE PATIENT'S ABDOMEN. THE ENTIRE TROCAR WAS REMOVED AND A NEW ONE WAS OPENED AND PLACED IN PATIENT'S ABDOMEN WITH NO ISSUES. FDA SAFETY REPORT ID # (B)(4). PRODUCT NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 10-JAN-2022 FROM USER FACILITY: A METAL RETRACTOR WAS NOT USED. THERE WAS NO PATIENT INJURY. AN ADDITIONAL 5 MM TROCAR [NON-APPLIED] WAS USED IN THE PROCEDURE. NO DAMAGE TO THE TUBING/BALLOON/BALLOON INFLATION PORT WAS NOTED. THIS WAS NOT A ROBOTIC PROCEDURE. NO SHARP INSTRUMENT CAME INTO CONTACT WITH THE BALLOON. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A NEW TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237757 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAPP. EVENT DESCRIPTION: WHEN PLACING THE TROCARS IN THE BEGINNING OF THE PROCEDURE, A CAP FELT OFF FROM ONE TROCAR INTO THE PATIENTS ABDOMEN. THIS HAPPENED TO DR. [NAME], THE HEAD OF GENERALISTS. NOTHING HAPPENED TO THE PATIENT AS THE INCIDENT WAS REMARKED IMMEDIATELY. THEY REMOVED THE CAP FROM THE PATIENTS ABDOMEN AND TOOK A NEW CFF73 FROM THE SAME BATCH. WITHOUT FURTHER PROBLEMS THE PROCEDURE COULD BE DONE. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: ALL RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911356 ↗
• MalfunctionOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC RIGHT HEMICOLECTOMY. EVENT DESCRIPTION: DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY THE INNER BASKET FROM THE HEAD/VALVE OF THE PORT BECAME SEPARATED FROM THE PORT AND DROPPED INTO THE ABDOMINAL CAVITY. FORTUNATELY, IT WAS NOTICED BY THE SURGEON AND THE PART COULD BE RETRIEVED. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 08NOV21: ALL PIECES WERE RETRIEVED. THE ENTIRE INSTRUMENT GUARD FELL OUT OF THE TROCAR. HAEMOLOCK INSTRUMENT. TYPE OF INTERVENTION: FRAGMENT WAS RETRIEVED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708432 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAPP LEISTENHERNIE. EVENT DESCRIPTION: THE PATIENT UNDERWENT INGUINAL HERNIA SURGERY THAT DAY AND AFTER INSERTING AND PLACING THE TROCARS, DR. [NAME] FOUND OUR DOUBLE SEAL IN PLACE. THE RETRIEVAL OF THE SEAL WAS WITHOUT COMPLICATIONS AND DID NOT PROLONG THE OPERATION SIGNIFICANTLY (5MIN). NO INSTRUMENTS OR SWABS WERE INSERTED THROUGH THE TROCAR YET, ACCORDING TO THE SURGEON, THE VALVE RELEASED WITHOUT MANIPULATION. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577577 ↗
• MalfunctionAug 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: COLECTOMY. EVENT DESCRIPTION: THE TROCAR WAS INSERTED AND AFTER THAT THE DOUBLE DUCK BILL WAS FOUND IN THE ABDOMEN. UNFORTUNATELY THE NURSE DISCARDED THE TROCAR, BUT THE DOCTOR MADE A PIC. ADDITIONAL INFORMATION FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21SEP2020: I RECEIVED THE ANSWER FROM THE HOSPITAL, THAT THE COMPLAINT WAS UNFORTUNATELY A MISTAKE, CAUSE OUR TROCAR WAS NOT AFFECTED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417901 ↗