Kii® Optical Access System C0R37Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00607915116422), received between Apr 1, 2016 and Sep 10, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725089 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Procedure Performed:VATS Lobectomie.Event Description:PCF was received with few information: How the device was being used is unknown. The description of the event is unknown. There is no clinical impact to the patient. Additional information received by an Applied Medical representative via email on 20Aug26:The product was used in the same way I observed before. They use rolled-up gauze during the procedure it insert and remove it through the trocar. I did not receive a photo of the product.It was ordered via Hospital Logistics, account ID (b)(4) - Lot confirmation was performed with this account.Additional information by an Applied Medical representative, via email on 21Aug26:The duck was in total released from the trocar.Closing letter requested.Intervention:Removing the double duck bill out of the patient.Patient Status:Ok.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525350 ↗
• MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC BANDING. EVENT DESCRIPTION: [TRANSLATION] PATIENT UNDERGOING LAPAROSCOPIC GASTRIC BANDING. WHEN THE RING WAS INTRODUCED THROUGH THE 15MM TROCAR, THE PNEUMOPERITONEUM SEAL TOPPED OUT AND RE-ENTERED THE ABDOMINAL CAVITY. CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT OR PERSON INVOLVED - RISK OF RUBBER MICROPARTICLES IN THE PATIENT'S ABDOMINAL CAVITY, THEY CHANGE OF TROCAR DAMAGED THE PATIENT'S SKIN. PATIENT MONITORING. RECEIVED ANSM SUBMITTED OF INCIDENT FORM ON (B)(6) 2025: DUPLICATE WAS PERFORMED AND THIS ANSM SUBMISSION WAS FOUND TO BE THIS COMPLAINT. NO NEW INFORMATION WAS RETRIEVED. ANSM REF NUMBER (B)(4). ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23MAY25: THE CHANGED OF THE TROCAR DAMAGED THE PATIENT'S SKIN. PATIENT STATUS, TM TO FOLLOW UP TO RELEVANT RESPONSIBLE PERSON. CONCOMITANT DEVICE: INSERTION OF A MID GASTRIC BAND, [DEVICE NAME]. LOT NUMBER CONFIRMED 1533241. INTERVENTION: CHANGE OF TROCAR. PATIENT STATUS: PATIENT MONITORING: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109871 ↗
• MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC PULMONARY LOBECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2 - (B)(4), COMPLAINT 2 OF 2 - (B)(4). [TRANSLATION] DURING A ROBOTIC PULMONARY LOBECTOMY IN ROOM 1 OF THE GENERAL WARD, THE INTERNAL REDUCING VALVE OF THE THE INTERNAL REDUCING VALVE OF THE 15 MM TROCAR ON REPEATED PASSAGE OF THE INSTRUMENTS, ON 2 OCCASIONS (2 TROCARS USED FROM 2 DIFFERENT BATCHES). DISCONNECTION OF THE VALVE COMPONENTS FROM THE 1ST TROCAR, PART OF WHICH FELL INTO THE THORACIC CAVITY. SEARCH FOR THE PART OF THE VALVE FROM THE 1ST TROCAR USED THAT FELL INTO THE THORACIC CAVITY. 2ND TROCAR VALVE BEFORE DISCONNECTING ITS COMPONENTS. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: FIND THE VALVE THAT HAS FALLEN INTO THE PATIENT'S THORAX AND REMOVAL. TYPE OF INTERVENTION: REMOVED THE VALVE. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345390 ↗
• MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC PULMONARY LOBECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2 - (B)(4) [BATCH ID: 2027111-20250210093621]. COMPLAINT 2 OF 2 - (B)(4) [BATCH ID: 2027111-20250210093754]. [TRANSLATION] DURING A ROBOTIC PULMONARY LOBECTOMY IN ROOM 1 OF THE GENERAL WARD, THE INTERNAL REDUCING VALVE OF THE INTERNAL REDUCING VALVE OF THE 15 MM TROCAR ON REPEATED PASSAGE OF THE INSTRUMENTS, ON 2 OCCASIONS (2 TROCARS USED FROM 2 DIFFERENT BATCHES). DISCONNECTION OF THE VALVE COMPONENTS FROM THE 1ST TROCAR, PART OF WHICH FELL INTO THE THORACIC CAVITY. SEARCH FOR THE PART OF THE VALVE FROM THE 1ST TROCAR USED THAT FELL INTO THE THORACIC CAVITY. 2ND TROCAR VALVE BEFORE DISCONNECTING ITS COMPONENTS. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: FIND THE VALVE THAT HAS FALLEN INTO THE PATIENT'S THORAX AND REMOVAL. TYPE OF INTERVENTION: REMOVED THE VALVE. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345382 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ROBOTIC PROCEDURE. EVENT DESCRIPTION: DURING LAPAROSCOPIC ROBOTIC PROCEDURE RUBBER INTERIOR OF 15MM TROCAR DETACHED INTO THE PATIENT'S CAVITY. THE OBJECT WAS REMOVED FROM THE PATIENT, THE TROCAR WAS REMOVED, AND BOTH WERE ASSESSED. IT WAS CONFIRMED THAT ALL PARTS OF THE DEFECTIVE TROCAR WERE REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY FACILITY REPRESENTATIVE ON 20 MAR 2024 VIA EMAIL: I DID SEQUESTER THIS TROCHAR FROM THE OR WHERE THE ISSUE OCCURRED. I AM ABLE TO SEND IT TO YOU FOR REVIEW. I AM UNSURE OF THE EXACT ATTACHMENT THAT WAS USED DURING THE PROCEDURE, BUT WHAT WAS DESCRIBED TO ME WAS THAT A RUBBER FLANGE ON THE TROCHAR FELL OFF INTO THE SURGICAL FIELD. IT WAS IMMEDIATELY RETRIEVED AND EXCHANGED. TYPE OF INTERVENTION: THE OBJECT WAS REMOVED FROM THE PATIENT, THE TROCAR WAS REMOVED, AND BOTH WERE ASSESSED. IT WAS CONFIRMED THAT ALL PARTS OF THE DEFECTIVE TROCAR WERE REMOVED FROM THE PATIENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976072 ↗
• MalfunctionSep 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER TWO DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY A BALLOON RUPTURE OCCURRED. THE PATIENT WAS TAKEN TO THE CATH LAB TO HAVE A NEW IAB INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. REPORTED VIA MEDWATCH # (B)(4): UPON NOTICING AUDIBLE IABP ALARM. L AXILLARY IABP ACCESS SITE NOTED TO HAVE BLOOD ALONG LENGTH OF THE RETURN LINE TUBING. TUBING WAS CLAMPED PROXIMALLY WITH A KELLY CLAMP. IABP WAS TURNED OFF, AND RETURN LINE DISCONNECTED AND PLACED IN A BIOHAZARD BAG FOR APPROPRIATE ANALYSIS. AFTER BLOOD WAS NOTED IN THE IABP TUBING, PUMP WAS TURNED OFF AND CARDIOVASCULAR TEAM NOTIFIED. PATIENT REQUIRED A PROCEDURE TO HAVE THE BALLOON PUMP EXCHANGED. CATH LAB WAS ACTIVATED FOR BALLOON PUMP EXCHANGE. AT THE END OF THE PROCEDURE, GOOD FUNCTION OF THE IABP CATHETER WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725731 ↗
• MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: GASTRIC BAND. EVENT DESCRIPTION: COMPLAINT 1 O F 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PHONE 15MAY23: DURING BARIATRIC SURGERY PROCEDURE A COMPONENT (SEPTUM) OF THE SEAL FELL INSIDE THE PATIENT DURING INSERTION OF THE GASTRIC BAND. THIS IS THE SECOND TIME THAT THIS TYPE OF INCIDENT OCCURRED. FIRST OCCURRENCE OF THIS EVENT HAS NOT BEEN DECLARED BY THE HOSPITAL. INFORMATION RECEIVED FROM PRODUCT COMPLAINT FORM (B)(6) 2023: DURING BARIATRIC SURGERY PROCEDURE A COMPONENT (SEPTUM) OF THE SEAL FELL INSIDE THE PATIENT DURING INSERTION OF THE GASTRIC BAND. NO CLINICAL IMPACT ON THE PATIENT AS A RESULT OF THE EVENT. ANOTHER TROCAR APPLIED WAS USED TO RESOLVE THE SITUATION. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 17MAY23: ALL PIECES OF THE SEPTUM RETRIEVED FROM THE PATIENT. I THINK THE PART WAS TORN OFF. THE SURGEON PASSED A GASTRIC BAND AT THE TIME OF THE INCIDENT. GRASPING FORCEPS WERE USED PRIOR TO THE INCIDENT. THE PART WAS THE SEPTUM. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. THE SAME MODEL TROCAR WAS USED TO RESOLVE THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17384672 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: REPORT NUMBER MW # (B)(4). A TROCAR WAS IN PLACE IN THE PATIENT. WHEN A LAPAROSCOPIC INSTRUMENT WAS INSERTED THROUGH THE TROCAR, A PIECE OF THE TROCAR BROKE OFF INTO THE PATIENT. THE PIECE WAS IDENTIFIED AND REMOVED FROM THE PATIENT. NO PATIENT HARM WAS REPORTED. THE TROCAR WAS REMOVED AND REPLACED. PRODUCT NOT AVAILABLE FOR RETURN. INTERVENTION: THE TROCAR WAS REMOVED AND REPLACED. PATIENT STATUS: NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682309 ↗
• MalfunctionFeb 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LOBECTOMY. EVENT DESCRIPTION: LIMITED INFORMATION IS AVAILABLE AT THE TIME OF REPORT. REP WAS NOT PRESENT FOR THE CASE. SURGEON STATED THAT PIECES OF THE TROCAR WERE FALLING OFF INTO THE PATIENT DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 03FEB2022 FROM APPLIED MEDICAL ACCOUNT MANAGER: THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A NEW TROCAR. A BABCOCK WITH A SPONGE ON IT WAS BEING INSERTED INTO THE TROCAR AT THE TIME OF THE EVENT. THE PROCEDURE BEING PERFORMED WAS A LOBECTOMY. THE ENTIRE CLEAR/WHITE SEAL COMPONENT FELL INTO THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. PRODUCT IS AVAILABLE FOR RETURN. IT IS UNKNOWN IF THEY WILL BE RETURNING THE UNITS. 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 13488603 ↗
• MalfunctionOct 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOT LOBECTOMY. EVENT DESCRIPTION: THE REP WAS NOT PRESENT DURING THE CASE. DURING THE CASE, PARTS OF THE SEAL BECAME DISLODGED AND FELL INTO THE PATIENT. THE SURGICAL TEAM INITIALLY FOUND A BLACK PIECE OF THE SEAL INSIDE THE PATIENT. WHEN THE SURGICAL STAFF WENT TO RETRIEVE THE PIECE FROM THE PATIENT THEY ALSO FOUND A CLEAR PIECE FROM THE TROCAR SEAL THAT WAS WITHIN THE PATIENT. BOTH PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE BLACK PIECE APPEARED TO HAVE BEEN A PIECE OF A SEAL COMPONENT AND NOT AN ENTIRE COMPONENT. IT IS UNKNOWN IF THE CLEAR PIECE WAS THE ENTIRE SHIELD OR JUST A FRAGMENT. THIS PROCEDURE USED A DA VINCI ROBOT BUT IT IS UNKNOWN WHAT OTHER INSTRUMENTS WERE USED IN THE CASE OR WHAT ACTIONS WERE BEING PERFORMED WHEN THE PIECES OF THE SEAL FELL INTO THE PATIENT. NO PATIENT INJURY. NO PRODUCT RETURN. PRODUCT WAS DISPOSED OF BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 FROM APPLIED MEDICAL ACCOUNT MANAGER: "I TALKED TO THE SCRUB NURSE. SHE SAID THE CASE WAS A LOBECTOMY AND THE DOCTOR HAD ONLY PUT SURGICAL PATTY¿S THROUGH THE TROCAR AND HAD DONE 10 OR SO EXCHANGES THROUGH IT WHEN THEY NOTICED THE BLACK SEAL I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616523 ↗
• MalfunctionAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UROLOGY CASE. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. WHEN INSERTING SOMETHING INTO THE CANNULA THE ENTIRE BLACK SEAL CAME OFF AND FELL INTO THE PATIENT. IT WAS NOTICED AND REMOVED IMMEDIATELY. THERE WAS NO PATIENT INJURY. PRODUCT NOT AVAILABLE FOR RETURN. IT WAS DISPOSED OF AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24AUG2021 FROM APPLIED MEDICAL REPRESENTATIVE: REP SPOKE TO THE CUSTOMER AND BOTH ARE UNSURE HOW THE CASE WAS COMPLETED OR WHAT WAS BEING INSERTED INTO THE TROCAR. TYPE OF INTERVENTION: THE SURGEON IMMEDIATELY REMOVED THE SEAL. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380569 ↗
• MalfunctionFeb 11, 2020Detachment of Device or Device Component; Gas/Air Leak; Detachment of Device or Device Component; Gas/Air Leak

  PROCEDURE PERFORMED: ROBOTIC ASSISTED COMPLETE CYSTECTOMY, ILEAL CONDUIT URINARY DIVERSION. EVENT DESCRIPTION: REP. WASN'T PRESENT FOR THE CASE. LIMITED INFORMATION IS AVAILABLE AT THE TIME OF REPORTING. THE EVENT OCCURRED ON (B)(6) 2019, BUT THE REP. WASN'T INFORMED OF THE EVENT UNTIL TODAY ON (B)(6) 2019 AND WAS ONLY ABLE TO TAKE A SNAPSHOT OF THE SHEET OF PAPER WITH THE EVENT DESCRIPTION THAT STATED THE FOLLOWING: "DURING PROCEDURE, INSUFFLATION WAS LOST AND SAW THAT TROCAR IS BROKEN." THE PRODUCT IS EXPECTED TO RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA MAIL ON JANUARY 23RD, 2020 FROM THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, MEDWATCH# 4500760000-2019-8006: DURING PROCEDURE, INSUFFLATION WAS LOST AND MD FOUND THAT TROCAR WAS BROKEN. THE SEAL FROM THE TROCAR DISLODGED AND WAS FOUND INSIDE OF THE PT. THE ORIGINAL INTENDED PROCEDURE WAS A ROBOTIC ASSISTED COMPLETE CYSTECTOMY, ILEAL CONDUIT URINARY DIVERSION. THE PROBLEM THAT THE USER HAD WAS THAT THE DEVICE FAILED (E.G. BROKE, COULDN'T GET IT WORK OR STOPPED WORKING). THIS IS NOT A LABORATORY DEVICE OR LABORATORY TEST. PATIENT STATUS: NO PATIENT ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695088 ↗
• MalfunctionJun 13, 2019Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: PANCREATECTOMY DISTAL AND SPLENECTOMY - LAPAROSCOPIC ROBOTIC ASSISTED. EVENT DESCRIPTION: MEDWATCH #2600320000-2019-8057 RECEIVED VIA MAIL ON 04JUN2019. DURING XI ROBOTIC LAPAROSCOPIC CASE, BLACK PIECE (APPROX. 1/4 INCH) FELL OFF TROCAR AND WAS FOUND IN ABDOMEN OF PATIENT. PIECE REMOVED. DATE OF EVENT: (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUN2019 FROM USER FACILITY: THERE WAS NO PATIENT INJURY. THERE WAS NO HARM TO PATIENT. DATE OF THE EVENT WAS (B)(6) 2019. THE PART OF THE SEAL THAT DETACHED IS UNKNOWN. IT IS UNKNOWN IF THE ENTIRE COMPONENT FELL OUT OR WAS TORN OFF. IT IS UNKNOWN WHAT INSTRUMENTATION WAS BEING USED AT THE TIME OF THE INCIDENT. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUN2019 FROM USER FACILITY: YES, I HAVE THE DEVICE. IT IS NOT THE FULL TROCAR, BUT RATHER A PIECE OF IT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10JUN2019 FROM USER FACILITY: I DON'T HAVE THE COPY OF THE FMD, BUT BELIEVE IT WAS THE 15MM TROCAR. THE INFORMATION BELOW IS FOR THE C0R37. THE DATE OF THE CASE WAS (B)(6) 2019. THE PROCEDURE WAS BEING PERFORMED WAS A XI PANCREATECTOMY DISTAL AND SPLENECTOMY- LAPAROSCOP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696435 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. "NOTICED BLACK AND CLEAR PLASTIC MISSING FROM INSIDE TROCAR AFTER USE." PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380281 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC CYSTECTOMY. EVENT DESCRIPTION: WHILE PLACING 15MM [NON-APPLIED] BAG THROUGH THE TROCAR, THE ENTIRE BLACK INNER SEAL CAME OFF OF THE TROCAR AND FELL INTO THE PATIENT'S BODY. SEAL WAS RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY. OPENED A NEW C0R37 AND COMPLETED THE PROCEDURE. PHOTOS ARE AVAILABLE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318256 ↗
• MalfunctionDec 22, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC GASTRIC SLEEVE" EVENT DESCRIPTION: CER 1 OF 2: (B)(4), CER 2 OF 2: (B)(4). "HAPPENED IN BOTH FIRST CASE AND SECOND CASE. PART OF THE SEAL FELL OFF IN THE PATIENT AND THEY HAD TO GO RETRIEVE IT. HAPPENED IN THE MIDDLE OF THE CASE. THE SURGEON WAS USING THE TROCAR." TYPE OF INTERVENTION: "PROCEDURE COMPLETED WITH NEW TROCAR" PATIENT STATUS: "THEY COULDN'T STATE ANYTHING ABOUT POTENTIAL FUTURE COMPLICATIONS, BUT NOTHING WAS WRONG THEN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7143516 ↗
• MalfunctionDec 22, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC GASTRIC SLEEVE." EVENT DESCRIPTION: CER 1 OF 2: (B)(4). CER 2 OF 2: (B)(4). "HAPPENED IN BOTH FIRST CASE AND SECOND CASE. PART OF THE SEAL FELL OFF IN THE PATIENT AND THEY HAD TO GO RETRIEVE IT. HAPPENED IN THE MIDDLE OF THE CASE. THE SURGEON WAS USING THE TROCAR." TYPE OF INTERVENTION: "PROCEDURE COMPLETED WITH NEW TROCAR." PATIENT STATUS: "THEY COULDN'T STATE ANYTHING ABOUT POTENTIAL FUTURE COMPLICATIONS, BUT NOTHING WAS WRONG THEN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7143514 ↗
• MalfunctionAug 31, 2017Fracture; Fracture

  PROCEDURE PERFORMED: GASTRIC SLEEVE. EVENT DESCRIPTION: DR. (B)(6) REPORTED THAT THE SLEEVE OF THE TROCAR IS LACERATED WHEN INSERTING IT INTO THE PATIENT. HE HAD THE IMPRESSION THAT THE SLEEVE "BENT". TROCAR WAS REPLACED BY ANOTHER. THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFO RECEIVED FROM REP VIA EMAIL ON 10AUG2017: ACCORDING TO THE USER, THE SLEEVE WAS FRAYED AND/OR TORN AT THE LOWER EDGE. TYPE OF INTERVENTION: N/A PATIENT STATUS: ACCORDING TO DR. (B)(6), PATIENT WAS NOT AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836619 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAP BAND - "THE SEAL BECAME DISLODGED AND WAS PUSHED THROUGH THE CANNULA WHEN THE LAP BAND WAS INSERTED." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372889 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC HIATAL HERNIA- "DURING THE PROCEDURE PNEUMO WAS BEING LOST. BEFORE CLOSING DR. FORTES DISCOVERED THAT A PIECE OF THE INNER SEAL HAD FALLEN INTO THE PATIENT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372826 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  SLEEVE GASTRECTOMY - "SURGEON ENTERED THE TROCAR WITH A EGIAUSTND STAPLER WITH A 60 BLACK SEAMGUARD. UPON ENTRY THE SURGEON NOTICED THAT A SMALL PART OF THE INNER BLACK SEAL OF THE TROCAR CAME OFF AND FELL INTO THE PATIENT. THE SURGEON NOTICED THIS AND RETRIEVED THE SEAL FROM THE PATIENT AND SWAPPED THE TROCAR FOR A NEW ONE. 2ND CONTACT: (B)(6)." PATIENT STATUS - UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372562 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "WHILST INSERTING THE LAP BAND, THE BLACK RUBBER SEAL (DOUBLE DUCKBILL) FELL INTO THE ABDOMEN. THE SEAL WAS RETRIEVED FROM THE PATIENT AND ANOTHER PORT WAS USED. SURGEON WAS MR. (B)(6)." PATIENT STATUS - "NO INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372480 ↗
• MalfunctionMar 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  "DR WANTED TO TRIAL 15X100MM PORT. DR PUT TWO SEAMGUARDS ON THE STAPLER AND IT WOULDN'T GO DOWN THE PORT. IT DID HOWEVER GO DOWN THE XCEL 15MM PORT." PATIENT STATUS: UNKNOWN. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370832 ↗
• MalfunctionFeb 8, 2017Detachment Of Device Component; Detachment Of Device Component

  LAP GASTRIC BAND - WHEN INSERTING THE GASTRIC BAND THROUGH THE TROCAR IN TO THE PATIENT, THE TEAM NOTICED THAT THE INNER BLACK SEAL OF THE TROCAR WAS INSIDE THE PATIENT AND LODGED OVER THE GASTRIC BAND. THE SURGEON REPLACED THE PORT WITH ANOTHER C0R37 AND RETRIEVED THE SEAL FROM THE PATIENT. TYPE OF INTERVENTION - "N/A". PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6311946 ↗