GelPOINT® Advanced Access Platform CNGL2Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00607915125325), received between May 10, 2016 and Sep 25, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (35 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906306 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906304 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892409 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Event Date Unknown. Procedure Performed: NI. Event Description: Plastic of the ring tears again and again - occurred multiple times last period. Additional information received from Applied Medical representative on 14July26: The person who reported does not know how many other incidents occurred. I will send her the questions too. Type of Intervention: NI. Patient Status: Patient is ok.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216115 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Procedure Performed: NI. Event Description: Plastic of the ring tears again and again - occurred multiple times last period. Additional information received from Applied Medical representative on 14July26: The person who reported does not know how many other incidents occurred. I will send her the questions too. Type of Intervention: NI. Patient Status: Patient is ok.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216113 ↗
• MalfunctionJun 9, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE HOSPITAL; IT WAS REPORTED THAT THE SHEATH AND INNER RING OF THE WOUND PROTECTOR HAD COME LOOSE UPON OPENING THE PACKAGE (THOUGH THIS MAY HAVE HAPPENED AFTER USE? WE PLAN TO VERIFY THIS AS THERE IS BLOOD ON THEM). NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH THE HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS NOT BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. ADDITIONAL INFORMATION PROVIDED BY PERSONNEL VIA EMAIL ON 09JUN2026: 1. DURING WHAT STEP IN THE PROCEDURE DID THE MALFUNCTION OCCUR? (PLACEMENT, MID-PROCEDURE, REMOVAL). ¿ IF THE TIME OF OCCURRENCE IS NOT KNOWN, AT WHAT POINT WAS THE DETACHMENT NOTICED? THE ISSUE OCCURRED DURING THE PROCEDURE, SPECIFICALLY AT THE INITIAL STAGE OF INSUFFLATION. DETAILS: AFTER THE START OF SURGERY, A SMALL INITIAL INCISION WAS MADE, AND THE GELPOINT WOUND PROTECTOR WAS SET. THE GEL CAP WAS THEN ATTACHED, AND INSUFFLATION WAS STARTED. A LEAK IN THE INSUFFLATION WAS NOTICED, SO THE INSUFFLATION WAS TEMPORARILY STOPPED. WHEN THE GEL CAP WAS REMOVED FOR INSPECTION, A DEFECT IN THE ALEXIS DEVICE WAS DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451665 ↗
• MalfunctionJun 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LASH. EVENT DESCRIPTION: I ATTENDED THE OPERATION. DEVICE WAS PLACED CORRECTLY - IT'S POSSIBLE THAT WHEN INSTALLING THE ALEXIS, THE SHEATH WAS TURNED INSIDE OUT ONE ROTATION TOO MANY. IT SEEMED LIKE A LOT OF PRESSURE. PATIENT WAS IN TRENDELENBURG POSITION, LAPAROSCOPE WAS INSERTED CAUDAD. THE SHEATH CAME LOOSE FROM THE INNER PURPLE RING DURING THE PROCEDURE. WHEN THE ALEXIS WAS BEING REMOVED, A LOOP OF INTESTINE BECAME ENTANGLED AROUND THE INNER PURPLE RING(THERE WAS NO SHEATH AT THIS POINT) SO THE RING HAD TO BE CUT. IT OCCURRED NO VISIBLE OR NOTICEABLE HARM TO THE PATIENT. THE SURGERY COULD CONTINUE, BUT IT WAS MUCH MORE DIFFICULT TO RESECT THE SPECIMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 29MAY26: I ALREADY ANSWERED MOST OF THE QUESTIONS IN THE COMPLAINT FORM ATTACHED. THE GELPOINT BEEN IN USE BEFORE THE SHEATH DETACHMENT FROM THE PURPLE INNER RING WAS OBSERVED ROUGHLY 30 MINUTES IN THE PROCEDURE. IT ENTRAPPED AFTER CUTTING THE PURPLE RING. THE SURGEON PERFORMED A TISSUE SWEEP BEFORE AND AFTER ROLLING THE ALEXIS DOWN. TYPE OF INTERVENTION: THE SURGERY COULD CONTINUE, BUT IT WAS MUCH MORE DIFFICULT TO RESECT THE SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417105 ↗
• MalfunctionJun 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: RIGHT COLECTOMY. EVENT DESCRIPTION: WHEN STRETCHING THE MEMBRANE TO POSITION THE ALEXIS, THE INTERNAL RING (PINK) DETACHED FROM THE MEMBRANE. NOTHING ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM NCA VIA EMAIL ON 27MAY26: DURING A RIGHT COLECTOMY, THE RETRACTOR PRESENTED A PROBLEM: THE TRANSPARENT SHEATH HAD BECOME DETACHED FROM THE RIGID RING. DELAY IN THE SURGERY. STRESS FOR THE SURGEON AND THE TEAMS. ADDITIONAL COSTS FOR THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01JUN26: THE RING DETACHED FROM THE MEMBRANE. NO LEAK, BROKEN DEVICE. IT HAPPENED AT THE TIME OF TIGHTENING THE ALEXIS. NO DAMAGE ON THE GELSEAL CAP. NO INSTRUMENTS PLACED DIRECTLY THROUGH THE GEL. THE LEAK DID NOT OCCUR ONLY WHEN INSTRUMENTATION WAS PLACED THROUGH THE TROCAR. ONLY CNGL2 INSTRUMENTATION WAS USED DURING THE PROCEDURE. NO COMPONENT SEPARATE FROM THE SLEEVE/TROCAR SEAL WHEN LEAKAGE OCCURRED. NO COMPONENT FALL OUT OR APPEAR TO BE TORN OFF. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02JUN26: THE PATIENT IS DOING VERY WELL. TYPE OF INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: PATIENT IS DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412338 ↗
• MalfunctionJun 4, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: TATME (DA VINCI ROBOTIC SURGERY). EVENT DESCRIPTION: DURING THE SURGICAL PROCEDURE, AFTER THE WOUND PROTECTOR HAD BEEN DEPLOYED INTO THE PATIENT'S INCISION SITE, A SEPARATION OCCURRED BETWEEN THE RING AND THE SHEATH. CONSEQUENTLY, PNEUMOPERITONEUM COULD NOT BE MAINTAINED DUE TO AIR LEAKAGE. THE ATTENDING SURGEON, WHO IS A FREQUENT USER OF THIS DEVICE, REPORTED THAT MULTIPLE SIMILAR INCIDENTS HAVE OCCURRED THIS YEAR, RAISING SERIOUS CONCERNS REGARDING THE PRODUCT'S CURRENT QUALITY CONTROL. PLEASE REFER TO THE FOLLOWING LIST OF CASES THAT THE PHYSICIAN HAS ALREADY REPORTED THIS YEAR. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 28MAY2026: THE SHEATH SEPARATED FROM THE INNER RING YES, THE INNER RING UNROLLED AT A POINT IN THE PROCEDURE NO OTHER INSTRUMENTS WERE USED TO PLACE THE ALEXIS NO, THE SHEATH AND INNER RING DETACHED CLEANLY AS A SINGLE PIECE. THERE WAS NO VISIBLE FRAGMENTATION OR PARTICULATE GENERATION. N/A, BECAUSE NO PARTICULATE WAS GENERATED. NO PARTICULATE FELL INTO THE PATIENT. TYPE OF INTERVENTION: USER REPLACED WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402631 ↗
• MalfunctionMay 15, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. EVENT DESCRIPTION: THE PLASTIC TORE OFF THE RING LOSING PRESSURE AND A SECOND PRODUCT WAS OPENED. THEY NOTICED IT RIGHT AWAY UPON INSUFFLATING THE ABDOMEN. ADDITIONAL INFORMATION PROVIDED BY COMPANY REPRESENTATIVE ON 05MAY2026: IT WAS NOT A ROBOTIC CASE. ADDITIONAL INFORMATION PROVIDED BY COMPANY REPRESENTATIVE ON 08MAY2026: THE LEAKAGE OCCURRED AT THE BEGINNING OF THE PROCEDURE. THEY BELIEVE THE LEAKAGE OCCURRED IN BETWEEN THE SHEATH AND RING WHERE IT WAS DISCONNECTED. THE LEAK DID NOT OCCUR ONLY WHEN INSTRUMENTATION WAS PLACED THROUGH THE TROCAR LAP INSTRUMENTS WERE USED DURING THE PROCEDURE, BUT DID NOT USE AS THEY DID NOT GAIN PNEUMO WITH DEFECTIVE DISCONNECTION OF SHEATH FROM RING. NO, THEY DID NOT OBSERVE A COMPONENT SEPARATE FROM THE SLEEVE/TROCAR SEAL WHEN LEAKAGE OCCURRED. NO, THE SURGEON DID NOT ATTEMPT TO RESOLVE THE LEAKAGE AS IT WAS CLEARLY DISCONNECTED 15 PRESSURE AND HIGH FLOW. UNKNOWN WHETHER THERE ARE ANY DAMAGES ON THE GELSEAL CAP PICTURES NOT AVAILABLE, WAS REDBAGGED THIS WAS NOT A ROBOTIC PROCEDURE UNKNOWN AT WHAT POINT DID THE SHEATH SEPARATION OCCUR (DURING INSERTION, MID-PROCEDURE, DURING REMOVAL),

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191854 ↗
• MalfunctionMay 1, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DATE OF EVENT: UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL CE VIA EMAIL ON 21APR26: WE HAVE RECEIVED ONE UNIT ASSOCIATED WITH COMPLAINT (B)(4) HOWEVER, UNDER COMPLAINT (B)(4), TWO CNGL2 UNITS WERE RETURNED, BOTH EXHIBITING SHEATH SEPARATION FROM THE INNER RING (SEE ATTACHED PHOTOS). ONE OF THESE UNITS HAD A CLEARLY DETACHED SHEATH. FOR THE SECOND UNIT, THE SHEATH SEPARATION WAS NOT IMMEDIATELY VISIBLE; I HAD TO UNROLL THE INNER RING TO OBSERVE DAMAGE TO THE ALEXIS, SO IT IS POSSIBLE THE CUSTOMER RETURNED THIS DEVICE WITHOUT REALIZING IT WAS DAMAGED. BASED ON THIS INFORMATION, WE WILL NEED TO CREATE A NEW COMPLAINT TO ACCOUNT FOR THE SECOND DEVICE RETURNED UNDER COMPLAINT (B)(4). INTERVENTION: NI PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062308 ↗
• MalfunctionMay 1, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DATE OF EVENT: UNKNOWN. AFTER INSERTION, THE FOIL RING WAS ALREADY TORN AND FRAYED. TYPE OF INTERVENTION: NI . PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062257 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: SURGEON AND STAFF NOTICED PNEUMO WAS LEAKING. UPON INVESTIGATING, THEY FOUND THAT THE ALEXIS SHEATH HAD SLID OFF FROM THE INNER PURPLE RING. THE GELPOINT WAS REMOVED AND A NEW GELPOINT WAS PLACED. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REP] VIA EMAIL ON 01APR2026: THE GELPOINT HAD BEEN IN USE FOR ABOUT AN HOUR BEFORE THE SHEATH DETACHMENT FROM THE PURPLE RING WAS OBSERVED. THE PURPLE RING WAS NOT UNROLLED AT ANY POINT BEFORE THE PROCEDURE. THE LEAKAGE OCCURRED ABOUT AN HOUR AFTER PLACING THE GELPOINT ½ WAY THROUGH THE PROCEDURE. LEAKING OCCURRED WHETHER THERE WAS AN INSTRUMENT IN THE GEL TROCAR SLEEVE OR NOT. NO COMPONENT SEPARATED FROM THE SLEEVE/TROCAR SEAL WHEN LEAKAGE OCCURRED. THERE ARE NO DAMAGES TO THE GELSEAL CAP. THERE WERE NO INSTRUMENTS USED WITH THE ALEXIS DURING PLACEMENT. INSTRUMENTS WERE USED IN THE GEL SLEEVES DURING THE PROCEDURE AND SUBSEQUENTLY, PASSED THROUGH THE ALEXIS INTO THE ABDOMINAL CAVITY. ADDITIONAL INFORMATION PROVIDED BY [NAME] VIA VOLUNTARY USER REPORT [MW (B)(4)] ON 09APR2026: THE WOUND PROTECTOR TORE DURING THE CASE RESULTING IN LOSS OF CO2 PNEUMO. WOUND PROTECTOR WAS REPLACED AND CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904984 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LEFT HEMICOLECTOMY EVENT DESCRIPTION: WE SAW THAT THE PLASTIC SEAL AT THE SLEEVE OF THE INNER RING OF THE ALEXIS (CNGL2) WAS LOOSE. TOOK A NEW ONE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02APR26: PART OF ALEXIS INNER RING DETACHED AT THE END OF THE PROCEDURE. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904959 ↗
• MalfunctionApr 3, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAVH. EVENT DESCRIPTION: DR. [NAME] WAS DOING A LAVH AND THE SHEATH OF THE RETRACTOR DETACHED AT THE INNER PURPLE RING ON ONE SIDE. HAPPENED WHEN CLOSING AT THE END OF THE COLPOTOMY. ADDITIONAL INFORMATION PROVIDED BY [ACCOUNT MANAGER] ON 04MAR2026 VIA EMAIL: COLPOTOMY WAS CLOSED VAGINALLY. AN 11MM TROCARS WAS PLACED WITH TOWER CLIPS IN THE 2.5 CM INCISION TO CREATE PNEUMO, AREA WAS INSPECTED, TROCAR WAS TAKEN OUT AND INCISION CLOSED. 12 PRESSURE. DO NOT KNOW THE FLOW. NO DAMAGES ON GELSEAL CAP. ADDITIONAL INFORMATION PROVIDED BY [ACCOUNT MANAGER] ON 05MAR2026 VIA EMAIL: IN USE APPROXIMATELY 1.5 HR BEFORE DETACHMENT. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE. NO INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776111 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: COLECTOMY EVENT DESCRIPTION: THIS OCCURRED DURING THE PROCEDURE: THE SHEATH OF THE RING COMPLETELY DETACHED FROM THE INTERNAL PURPLE RING WITHOUT ANY TEARING, WHICH CAUSED SIGNIFICANT LEAKAGE AND THEREFORE REQUIRED THE REPLACEMENT OF THE DEVICE WITH ANOTHER ONE. THIS OCCURRED WHEN HE REMOVED THE DEVICE THROUGH THE ALEXIS GEL PORT AND THEN RETURNED TO THE LAPAROSCOPIC APPROACH. THERE WAS SIGNIFICANT GAS LEAKAGE. THEY USED A NEW GEL POINT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12MAR26: NO PICTURE HAS BEEN PROVIDED. THE LEAKAGE OCCURRED DURING PROCEDURE. THE GELPOINT BEEN IN USE FOR 1 HOUR BEFORE THE SHEATH DETACHMENT FROM THE PURPLE INNER RING WAS OBSERVED. THE PURPLE INNER RING WAS UNROLLED DURING PROCEDURE. PRESSION WAS SET TO 10 FLOW 35. NO DAMAGES ON THE GELSEAL CAP. INTERVENTION: THEY USED A NEW GEL POINT. PATIENT STATUS: PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758305 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  DATE OF EVENT: UNKNOWN PROCEDURE PERFORMED: ROBOTIC PROSTATE. EVENT DESCRIPTION: INFORMATION PROVIDED BY [ACCOUNT REP] VIA PHONE CALL ON (B)(6) 2026: DURING A PROSTATE SURGERY THE SHEATH SPLIT INSIDE THE PATIENT LEADING TO LEAKED PNEUMOPERITONEUM. INFORMATION PROVIDED BY [APPLIED MEDICAL TEAM MEMBER] VIA TEAMS MESSAGE ON 09MAR2026: HI [NAME]! AN APPLIED ACCOUNT REP, [NAME], HAS HEARD THAT THERE IS A COMPLAINT REGARDING A CNGL2 DEVICE AT [USER FACILITY]. I WAS WONDERING IF YOU HAVE ANY INFORMATION REGARDING THIS EVENT? [NAME]: I DO NOT HAVE ANY INFORMATION REGARDING THIS EVENT. I HAVE BEEN TRYING TO FOLLOW UP WITH THE ACCOUNT REGARDING THIS, HOWEVER I HAVE NOT HEARD ANYTHING BACK INFORMATION PROVIDED BY [APPLIED MEDICAL TEAM MEMBER] VIA EMAIL ON 25MAR2026: THE LOT NUMBER IS UNKNOWN AS THE DEVICE WAS NOT SAVED. THE EVENT DATE CANNOT BE CONFIRMED AND IT HAPPENED A FEW WEEKS AGO. THE PROCEDURE IS A ROBOTIC PROSTATE. A NEW GELPOINT WAS OPENED AND REPLACED THE ALEXIS TO COMPLETE THE PROCEDURE. THE ROBOTIC TROCAR/CAMERA AND 10MM GELPOINT SLEEVE WERE USED ALONG WITH THE CNGL2. THE SHEATH SEPARATED FROM THE OUTER RING. NO INSTRUMENTS WERE USED WITH THE ALEXIS DURING PLACEMENT. THERE ARE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737394 ↗
• MalfunctionMar 20, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY. EVENT DESCRIPTION: DURING A PROSTATE SURGERY THE SHEATH SPLIT INSIDE THE PATIENT LEADING TO LEAKED PNEUMOPERITONEUM. THE SHEATH WAS REMOVED FROM THE PATIENT AND THE PATIENT IS FINE. ADDITIONAL INFORMATION PROVIDED BY [NAME] VIA EMAIL ON 17MAR2026: THE NAME OF THE PROCEDURE IS A ROBOTIC PROSTATECTOMY. THE SHEATH TORE AWAY FROM THE OUTER RING. THE SURGICAL TEAM OPENED AN ADDITIONAL GELPOINT AND PLACED ANOTHER ALEXIS TO COMPLETE THE PROCEDURE. NO SHARPS WERE USED DURING PLACEMENT OF THE ALEXIS. THERE WAS A ROBOTIC TROCAR PLACED IN THE CAP, AS WELL AS A 10MM TROCAR FROM THE GELPOINT PACK USED DURING THE PROCEDURE. THERE WERE NOT ANY DAMAGES TO THE CAP. INTERVENTION: OPENED AN ADDITIONAL GELPOINT AND PLACED ANOTHER ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656109 ↗
• MalfunctionMar 20, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: INDEED, DURING MY OPERATION, THE SKIRT DETACHED FROM THE INNER RING AND REQUIRED A ¿HOMEMADE¿ REPAIR. PLEASE TAKE THE NECESSARY STEPS TO REPLACE THIS NON-FUNCTIONAL EQUIPMENT. INTERVENTION: "HOMEMADE" REPAIR PATIENT STATUS: NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656043 ↗
• MalfunctionMar 20, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: COLECTOMY EVENT DESCRIPTION: THIS OCCURRED DURING THE PROCEDURE: THE SHEATH OF THE RING COMPLETELY DETACHED FROM THE INTERNAL PURPLE RING WITHOUT ANY TEARING, WHICH CAUSED SIGNIFICANT LEAKAGE AND THEREFORE REQUIRED THE REPLACEMENT OF THE DEVICE WITH ANOTHER ONE. THIS OCCURRED WHEN HE REMOVED THE DEVICE THROUGH THE ALEXIS GEL PORT AND THEN RETURNED TO THE LAPAROSCOPIC APPROACH. THERE WAS SIGNIFICANT GAS LEAKAGE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27FEB26: THE LEAKAGE OCCURRED DURING PROCEDURE. THE INNER SHEATH OF THE ALEXIS OF THE GELPOINT BECAME DETACHED. LEAKAGE WAS RESOLVED BY USING A NEW GEL POINT. PRESSURE SET AT 12 MMHG AND FLOW SET AT 25. NO DAMAGES ON THE GEL SEAL CAP. DEVICE WAS USED AROUND ONE HOUR AND HALF/ TWO HOURS BEFORE THE SHEATH DETACHES FROM THE RING. IT WAS DURING THE PROCEDURE. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654803 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAR EVENT DESCRIPTION: THERE WERE FOUR CONSECUTIVE FAILURES REPORTED WITH THE CNGL2 MODEL, WHERE THE PROTECTIVE SHEATH DETACHES FROM THE RING DURING SETUP, AND THE BATCHES ASSOCIATED WERE 1563242 AND 1564833.. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: THERE IS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271422 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: THERE WERE FOUR CONSECUTIVE FAILURES REPORTED WITH THE CNGL2 MODEL, WHERE THE PROTECTIVE SHEATH DETACHES FROM THE RING DURING SETUP, AND THE BATCHES ASSOCIATED WERE 1563242 AND 1564833. INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271323 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAR EVENT DESCRIPTION: DURING INITIAL SETUP, AS THE SURGICAL TEAM ATTEMPTED TO INSERT THE WOUND RETRACTOR COMPONENT INTO THE INCISION AND ENGAGE THE RETRACTION MECHANISM, THE RETRACTOR RING BECAME COMPLETELY DETACHED FROM THE PROTECTIVE SHEATH WHILE ATTEMPTING TO DILATE THE WOUND. THIS RESULTED IN A LOSS OF RETRACTION AND INABILITY TO MAINTAIN A STABLE ACCESS PLATFORM. A SECOND UNIT OF THE SAME PRODUCT WAS OPENED AND ATTEMPTED UNDER STERILE CONDITIONS. UNFORTUNATELY, THE SAME FAILURE OCCURRED AGAIN¿THE RING SEPARATED FROM THE SHEATH DURING WOUND RETRACTION, RENDERING THE DEVICE NON-FUNCTIONAL. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 25JAN2026: THE SHEATH SEPARATED FROM THE INNER RING. YES, THE INNER RING WAS PROPERLY UNROLLED. THE CUSTOMER REPORTED THAT APPROXIMATELY 3-5 MINUTES AFTER PLACEMENT, AN AIR LEAK WAS AUDIBLE, AND UPON INSPECTION, IT WAS FOUND THAT THE RING HAD SEPARATED FROM THE SHEATH. NO OTHER INSTRUMENTS WERE USED TO PLACE THE ALEXIS. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271290 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAR. EVENT DESCRIPTION: DURING INITIAL SETUP, AS THE SURGICAL TEAM ATTEMPTED TO INSERT THE WOUND RETRACTOR COMPONENT INTO THE INCISION AND ENGAGE THE RETRACTION MECHANISM, THE RETRACTOR RING BECAME COMPLETELY DETACHED FROM THE PROTECTIVE SHEATH WHILE ATTEMPTING TO DILATE THE WOUND. THIS RESULTED IN A LOSS OF RETRACTION AND INABILITY TO MAINTAIN A STABLE ACCESS PLATFORM. A SECOND UNIT OF THE SAME PRODUCT WAS OPENED AND ATTEMPTED UNDER STERILE CONDITIONS. UNFORTUNATELY, THE SAME FAILURE OCCURRED AGAIN¿THE RING SEPARATED FROM THE SHEATH DURING WOUND RETRACTION, RENDERING THE DEVICE NON-FUNCTIONAL. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. ADDITIONAL INFORMATION PROVIDED BY "[DISTRIBUTOR]" ON 25JAN2026: THE SHEATH SEPARATED FROM THE INNER RING. YES, THE INNER RING WAS PROPERLY UNROLLED. THE CUSTOMER REPORTED THAT APPROXIMATELY 3-5 MINUTES AFTER PLACEMENT, AN AIR LEAK WAS AUDIBLE, AND UPON INSPECTION, IT WAS FOUND THAT THE RING HAD SEPARATED FROM THE SHEATH. NO OTHER INSTRUMENTS WERE USED TO PLACE THE ALEXIS. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271187 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09JAN2026: DURING THE CASE, THE BLACK FLANGE CAME OUT OF ONE OF THE PURPLE SLEEVES FOUND AS PART OF THE DEVICE (WHICH IS SUPPOSED TO BE FIXED IN SITU). DEVICE NOT REPLACED. CONSULTANT PUT HIS FINGER OVER THE PORT TO PREVENT THE GAS FROM ESCAPING AND COMPLETED THE CASE. INTERVENTION: DEVICE NOT REPLACED. CONSULTANT PUT HIS FINGER OVER THE PORT TO PREVENT THE GAS FROM ESCAPING AND COMPLETED THE CASE. PATIENT STATUS: FINE/NO ISSUES OR IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180277 ↗