GelPOINT® Mini Advanced Access Platform CNGL3Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00607915131784), received between May 9, 2016 and Oct 16, 2025 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPY MYOMECTOMY. EVENT DESCRIPTION: AFTER PROPER PLACEMENT OF THE CNGL3, A MINOR GAS LEAK WAS NOTED BUT DID NOT INITIALLY IMPACT THE PROCEDURE. HOWEVER, A SIGNIFICANT LOSS OF PNEUMOPERITONEUM OCCURRED WHEN ATTEMPTING TO INSERT A SPECIMEN RETRIEVAL BAG. THE GELSEAL CAP WAS THEN OPENED AS PART OF THE STANDARD PROCEDURE TO FACILITATE THE RETRIEVAL OF THE MYOMA. UPON OPENING, IT WAS DISCOVERED THAT THE VALVE FROM THE SLEEVE HAD DETACHED AND FALLEN INTO THE PATIENT'S ABDOMINAL CAVITY. THE VALVE WAS SUCCESSFULLY RETRIEVED BY THE SURGEON. RELEVANT PHOTOS ARE ATTACHED FOR YOUR REFERENCE. THERE IS NO IMPACT TO PATIENT. NO INTERVENTION WAS REQUIRED. THERE IS NO OTHER INSTRUMENTS TO AFFECT THIS EVENT. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 08OCT2025 VIA EMAIL: NO, THIS WAS NOT A ROBOTIC SURGERY. NO, AN AIRSEAL INSUFFLATOR WAS NOT USED. THE CO2 LEAKAGE WAS PERSISTENT. STANDARD 5MM INSTRUMENTS AND A 5MM LAPAROSCOPE WERE USED THROUGHOUT THE PROCEDURE. INITIALLY, THE LEAK APPEARED TO ORIGINATE FROM THE PERIPHERY OF THE ALEXIS WOUND PROTECTOR. SUBSEQUENTLY, A MASSIVE LEAK OCCURRED DUE TO THE COMPLETE DETACHMENT OF THE TROCAR'S VALVE. THE ENTIRE VALVE DETACH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316546 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: THEY SETUP THE GELPOINT, IT WAS TWO TROCARS AND THE GELPOINT. THEY PUT EVERYTHING IN THE GELPOINT, THE SPECIFIC TROCAR THAT COMES WITH THE GELPOINT AND ASSIST PORT, THE CLEAR PLASTIC INNER RING SEAL POPPED OUT FROM THE TROCAR AND WAS IN THE PATIENT. THEY DO NOT KNOW WHEN THAT HAPPENED BUT THEY SAW IT POP OUT. THE TROCAR THAT GOES THROUGH THE GELPOINT BROKE. THEY PULLED THAT PLASTIC PIECE OUT OF THE PATIENT THROUGH THE TROCAR THAT BROKE. PARTS OF THE PRODUCT ARE AVAILABLE FOR RETURN: SAVED THE GELCAP AND THE TROCAR. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REP] ON 21JUL2025: WE TRIED TO FIND THE LOT NUMBER BUT THE BOX AND PACKAGING WAS AT THE BOTTOM OF A DIRTY TRASH AND INFECTION PREVENTION WAS IN THE ROOM. I DON¿T HAVE ANY PHOTOS BUT SAVED THE PRODUCT AND WILL SEND IT AS SOON AS I GET THE LABEL. WE DO NOT NEED A BOX EITHER. THEY STARTED THE CASE BY PUTTING A 10MM TROCAR PORT AND A ROBOTIC CAMERA PORT IN THE GELPOINT MINI. THEY PUT THE GELPOINT MINI IN THE UMVILICUS AND THEN PLACED LATERAL ROBOT PORTS, LEAVING THE 2ND GELPOINT MINI PORT AS AN ASSIST PORT FOR SUCTION, GRASPING AND PASSING NEEDLES. AT SOME POINT DURING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710052 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  PROCEDURE PERFORMED: MYOMECTOMY AND LYSIS OF ADHESIONS EVENT DESCRIPTION: DURING SURGERY THEY FOUND A PIECE IN THE PERITONEUM THAT APPEARED TO BE A PART OF THE SEAL HOUSING. THEY WERE ABLE TO RETRIEVE THE PIECE FROM THE BODY. ON THE ACTUAL TROCAR THAT COMES WITH THE CNGL3 THERE IS A BLACK RUBBER DUCKBILL SEAL AND A CLEAR PIECE THAT IS EITHER BEFORE OR BEHIND THAT SEAL THAT LOOKS LIKE IT HAS COME OUT. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REPRESENTATIVE] ON 11JUN2025: THE TROCAR/SLEEVE DISLODGED FROM THE GEL 3 HOURS INTO THE CASE. IT IS UNKNOWN WHETHER THE SURGEON RE-INSERTED THE TROCAR IN A NEW POSITION OF THE GELSEAL CAP. NOTHING REPORTED ON THE TROCAR SLIPPING. NOTHING REPORTED REGARDING THE TROCAR SLIPPING OUT OF THE GELSEAL CAP DURING TORQUING/MOVEMENT OF INSTRUMENTATION. NOTHING REPORTED ON ANY ANGLED INSTRUMENTATION USED. THE PRODUCT IS STILL AT [USER FACILITY] AND SHOULD BE SHIPPED OUT THIS WEEK ONCE [INITIAL REPORTER] WILL RELEASE PRODUCT. INTERVENTION: ARTIFACT OR PIECE WAS TAKEN OUT THROUGH CNGL3 PATIENT STATUS: PATIENT WAS NOT INJURED, CASE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214137 ↗
• MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP BSO. EVENT DESCRIPTION: THE SURGEON WAS TRYING TO INTRODUCE AN INSTRUMENT THROUGH ONE OF THE TROCARS WHEN THEY HEARD A POP SOUND AND UPON INVESTIGATION IT WAS APPARENT THAT THE WHOLE INSTRUMENT GUARD FROM ONE OF THE TROCARS HAD BEEN DETACHED FROM THE TROCAR. IT WAS FULLY INTACT, SO THE SURGEON CONTINUED AND FINISHED THE CASE. THEY HAD USED 2 RETRIEVAL BAGS ON STICKS THROUGH THE TROCAR PRIOR TO THE INCIDENT. INTERVENTION: NI. PATIENT STATUS: RECOVERING POST OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110807 ↗
• MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: DIAGNOSTIC LAPAROSCOPIC CASE. EVENT DESCRIPTION: FROM THE ACCOUNT MANAGER: I WAS NOTIFIED TODAY THAT A DOCTOR WAS DOING A DIAGNOSTIC LAPAROSCOPIC CASE WITH THE GELPOINT MINI CNGL3 AND A PIECE FEEL OUT OF THE TROCAR AND WAS FOUND AND REMOVED FROM THE PATIENT WITH NO HARM. THE ACCOUNT HAS KEEP THE DEVICE WITH LOT # 1546692 WITH EXPIRATION OF 2028-03-05 AT THE HOSPITAL IF NEEDED. PLEASE ADVISE ON NEXT STEPS. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 16MAY2025: THIS WAS NOT A ROBOTIC SURGERY. THE LEAKAGE OCCURRED AT THE SLEEVE. THE LEAK DID NOT ONLY OCCUR WHEN INSTRUMENTATION WAS PLACED THROUGH THE TROCAR. IT WAS OBSERVED THAT A COMPONENT SEPARATED FROM THE SLEEVE/TROCAR SEAL WHEN LEAKAGE OCCURRED. THE ENTIRE COMPONENT FELL OFF AND FELL INTO THE PATIENT. THE SURGEON ATTEMPTED TO RESOLVE THE LEAKAGE AND REMOVED THE SLEEVE. THE PRESSURE AND FLOW WERE SET TO 40 PRESSURE/15 FLOW. THE WERE NO DAMAGES TO THE GELSEAL CAP. INTERVENTION: FOUND AND REMOVED FROM THE PATIENT WITH NO HARM. PATIENT STATUS: NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066928 ↗
• MalfunctionApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: SUTURE WITH A NEEDLE WAS BEING PASSED THROUGH GELPOINT MINI 10MM SLEEVE INTO THE ABDOMINAL CAVITY WITH A LAPAROSCOPIC GRASPER. WHILE PASSING SUTURE WITH A NEEDLE THROUGH THE GELPOINT MINI SLEEVE, A COMPONENT OF THE SLEEVE'S SEAL WAS OBSERVED FALLING OUT OF SLEEVE AND INTO THE ABDOMINAL CAVITY. HOSPITAL CONTACT DESCRIBED THE COMPONENT AS "CLEAR AND CIRCULAR". ITEM WAS IMMEDIATELY RETRIEVED AND REMOVED FROM ABDOMINAL CAVITY. REMOVED SLEEVE FROM GELPOINT CAP. LAPAROSCOPIC GRASPERS AND SUTURE WITH NEEDLE. INTERVENTION: REMOVED SLEEVE FROM GELPOINT CAP. PATIENT STATUS: NO CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923246 ↗
• MalfunctionApr 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOIDECTOMY. EVENT DESCRIPTION: [(B)(6)]. "PORT INSERTED BUT NOT LOCKED". ADDITIONAL INFORMATION RECEIVED BY DISTRIBUTOR ON (B)(6) 2025 VIA EMAIL: " IT WAS STATED THAT THE PROBLEM WAS RELATED TO THE SEPARATION OF THE GEL SEAL COVER." ADDITIONAL INFORMATION RECEIVED BY DISTRIBUTOR ON (B)(6) 2025 VIA EMAIL: " IT HAPPENED IN THE BEGINNING OF THE PROCEDURE. NO, THE LEVER WASN'T BROKEN THE CAP WAS PLACED ON ALEXIS PROPERLY. THEY KEPT RUNNING PROCEDURE ANYWAY IT WAS EVERYTHING WAS WHERE THEY WERE SUPPOSED TO BE, THE LEVER JUST DIDN'T LOCK UP." CONFIRMED ON (B)(6) 2025: EVENT UNIT RECEIVED HAD A TORN SHEATH ADDITIONAL INFORMATION RECEIVED BY DISTRIBUTOR ON (B)(6) 2025 VIA EMAIL: CONFIRMED BY ACCOUNT TO BE THE CORRECT UNIT FOR THIS COMPLAINT. NO INFORMATION WAS AVAILABLE AS TO THE INCIDENT SURROUNDING THE SHEATH TEAR AND THE TEAR WAS NOT MENTIONED IN THE ORIGINAL PRODUCT COMPLAINT. INTERVENTION: THE DEVICE WAS USED UNTIL THE END OF THE OPERATION. PATIENT STATUS: NO CLINICAL IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887082 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: EVENT DESCRIPTION: [HOSPITAL]. "THE TRANSPARENT SEAL (SHIELD) LOCATED AT THE UPPER PART OF THE INNER PASSAGE OF THE CANNULA, WHICH IS USED FOR INSERTING INTO THE GELPOINT CAP HAS DETACHED." ONLY SOME PARTS (SLEEVE) OF PRODUCT IS AVAILABLE FOR RETURN, NOT THE ENTIRE PRODUCT. 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 21853295 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ENDOSCOPIC NIPPLE SPARING MASTECTOMY. EVENT DESCRIPTION: GELPOINT MINI WAS PLACED IN A 3.5MM AXILLARY INCISION. 3 X 10MM TROCARS HAVE BEEN PLACED IN THE GELSEAL CAP. AFTER 1HOUR AND 40 MINUTES OF SURGERY, AN IMPORTANT LEAKAGE OF CO2 HAS BEEN IDENTIFIED. LOOKING CLOSER TO THE DEVICE IT APPEARS THAT ONE TROCAR IS LEAKING AND THAT THE INSTRUMENT SHIELD HAS BEEN PUSHED INTO THE SLEEVE OF THE TROCAR. THE DAMAGED TROCAR HAS BEEN REMOVED AND REPLACED BY THE REMAINING 12MM TROCAR. REPLACED THE 10MM TROCAR BY THE REMAINING 12MM TROCAR. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 08JAN25: YES LEAK CAME THROUGH THE TROCAR. THE LEAKING OCCURRED FOR 3-4 MINUTES. ONLY WHEN INSTRUMENTS WHERE IN THE TROCAR, THE LEAK OCCURRED. NO EXCESSIVE FORCE WAS NECESSARY TO INSERT THE INSTRUMENT. COMPONENT SEPARATE FROM THE SEAL WHEN LEAKING OCCURRED. NO PARTICULATION FELL INTO PATIENT. REPLACED TROCAR BY THE 12MM PORT . NO SLIT WAS CUT BY THE SURGEON IN THE GEL AT ANY TIME. INTERVENTION: REPLACED THE 10MM TROCAR BY THE REMAINING 12MM TROCAR. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172482 ↗
• MalfunctionDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ILESOTOMY REVERSAL. EVENT DESCRIPTION: MINI GELPORT, 1 TROCAR HAD PLASTIC PART COME OFF INSIDE OF PATIENT. ILESOTOMY REVERSAL, SMALL BOWEL RESECTION, PARASTOMAL HERNIA REPAIR, COMPLEX ROBOTIC ASSISTED VENTRAL HERNIA REPAIR WITH MESH PLACEMENT, EXTENSIVE LYSIS OF ADHESIONS. DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) EVENT DATE: NOVEMBER 2024. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 20DEC2024 VIA EMAIL (ENTERED BY (B)(6)): NO PATIENT INJURY OCCURRED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DEFECTIVE DEVICE WAS REMOVED FROM THE SURGICAL FIELD AS AN INTERVENTION. THE PRODUCT IS AVAILABLE FOR RETURN. YES, THIS WAS A ROBOTIC SURGERY. NO CREDIT OR REPLACEMENT IS NEEDED. AN AIRSEAL INSUFFLATOR WAS USED DURING THE SURGERY. YES, A COMPONENT SEPARATED FROM THE SLEEVE/TROCAR SEAL. AN ENTIRE COMPONENT FELL OUT. THE COLOR WAS CLEAR. IT FELL INTO THE PATIENT BUT WAS RETRIEVED. INTERVENTION: DEFECTIVE DEVICE WAS REMOVED FROM THE SURGICAL FIELD PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044660 ↗
• MalfunctionNov 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: HYSTERECTOMY, LAPAROSCOPIC TOTAL (LTH) WITH SALPINGO-OOPHERECTOMY OF UTERUS GREATER THAN 250G. EVENT DESCRIPTION: A PIECE OF THE WOUND RETRACTOR MEASURING 3MM THAT WAS TORN OFF BY THE GRASPER. THE DEVICE WORKED AS IT SHOULD. THE STAFF DESCRIBED MEDICAL DOCTOR GRABBING THE BAG RIGHT UNDER THE GREEN RING WITH A GRASPER AND A PIECE OF THE BAG TORE OFF AND DROPPED INTO THE ABDOMEN. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 14NOV2024 THE PATIENT WAS DISCHARGED. NO PATIENT INJURY OR ILLNESS WAS ASSOCIATED WITH THE COMPLAINT EVENT. THE PRODUCT PARTICULATED. THE PARTICULATED PART FELL INTO THE PATIENT. ALL OF THE MATERIAL WAS RETRIEVED. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 18NOV2024 THE RETRACTOR WAS USED FOR THE REMAINDER OF THE SURGERY. A SEARCH WAS COMPLETED TO LOCATE THE MISSING PIECE. INTERVENTION: THE RETRACTOR WAS USED FOR THE REMAINDER OF THE SURGERY. A SEARCH WAS COMPLETED TO LOCATE THE MISSING PIECE. PATIENT STATUS: DISCHARGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758868 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: REDUCE PORT SURGERY EVENT DESCRIPTION: GELPOINT WAS PLACED INTO A 2.5CM INCISION AT THE UMBILICUS FOR SPECIMEN EXTRACTION AND FOR REDUCE PORT SURGERY. THE CAMERA WAS PLACED THROUGH A 10MM SLEEVE AND A SEPARATE 10MM SLEEVE WAS PLACED THROUGH THE GEL FOR THE ASSIST PORT. WHEN THE SURGEON FINISHED MORCELLATING THE SPECIMEN HE RECAPPED THE GELPOINT TO TAKE A FINAL LOOK IN THE ABDOMEN AND NOTICED THE CLEAR PLASTIC PIECE THAT COMES INSIDE THE SLEEVE HAD DETACHED AND WAS LAYING ON TOP OF THE PATIENT'S BOWEL. HAD HE NOT TAKEN A FINAL LOOK, THE PLASTIC PIECE COULD HAVE BEEN LEFT IN THE PATIENT'S ABDOMEN. NO ADDITIONAL PRODUCT NEEDED TO BE PULLED SINCE IT WAS NOTICED AT THE END OF THE PROCEDURE. TYPE OF INTERVENTION: NO ADDITIONAL PRODUCT NEEDED TO BE PULLED SINCE IT WAS NOTICED AT THE END OF THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604575 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE BEING PERFORMED: GENETIC PREDISPOSITION TO MALIGNANT NEOPLASM. DETAILED DESCRIPTION OF EVENT: THE DEVICE WAS USED CORRECTLY WITHOUT FORCING, AN INTERNAL TRANSPARENT PIECE OF ONE OF THE TROCARS FELL INTO THE SURGICAL FIELD, THEY PUT THE PIECE BACK IN THE TROCAR AND CONTINUED WITH THE USE OF THE DEVICE WITHOUT PROBLEM. TYPE OF INTERVENTION: AN INTERNAL TRANSPARENT PIECE OF ONE OF THE TROCARS FELL INTO THE SURGICAL FIELD,THEY PUT THE PIECE BACK IN THE TROCAR AND CONTINUED WITH THE USE OF THE DEVICE WITHOUT PROBLEM. PATIENT STATUS: UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19112140 ↗
• InjuryApr 12, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: ENDOSCOPIC NIPPLE-SPARING MASTECTOMY EVENT DESCRIPTION: THE DEVICE WAS USED TO PERFORM A BILATERAL ENDOSCOPIC NIPPLE SPARING MASTECTOMY. DURING THE PROCEDURE, THE SURGEON NOTICED DAMAGE TO THE SKIN EDGES, LESION-LIKE ABRASIONS, AFTER REMOVING THE DEVICE, PARTICULARLY IN THE SECOND BREAST. AN OPEN DISSECTION WAS CONDUCTED PRIOR TO THE PLACEMENT OF THE GELPOINT MINI. DURING THIS DISSECTION, THE SURGEON UTILIZED A METAL RETRACTOR AND A MONOPOLAR PEN FOR DISSECTION. IT SEEMS THAT THE SURGEONS MAY HAVE ROLLED OVER THE ALEXIS. ADDITIONALLY, THERE WAS SIGNIFICANT MANIPULATION OF THE DEVICE, WITH MOVEMENT UP AND DOWN DURING DISSECTION. THE INCISION SKIN EDGES WERE DAMAGED. THE SURGEON TRIMMED THE EDGES OF THE SKIN BEFORE SUTURING THE INCISION. INTERVENTION: THE SURGEON TRIMMED THE EDGES OF THE SKIN BEFORE SUTURING THE INCISION. PATIENT STATUS: YES, THE INCISION SKIN EDGES WERE DAMAGED.

  Patient problems: Abrasion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098712 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ENDOSCOPIC NIPPLE-SPARING MASTECTOMY EVENT DESCRIPTION: IT WAS OBSERVED DURING A CADAVER LAB, THAT THE SHIELD FROM THE TROCAR SLEEVE BECAME DISLODGED. THE SHIELD WAS FOUND IN THE BREAST CAVITY. FOLLOWING THE PROCEDURE THE SHIELD WAS RETRIEVED AND NO OTHER COMPONENTS WERE FOUND. INTERVENTION: NA PATIENT STATUS: NA - CADAVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974858 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE PERFORMED: RATS+ND2. EVENT DESCRIPTION: HOSPITAL: [NAME]. "[NAME] WITNESSED THE CLINICAL USE OF THE GELPOINT MINI IN A RATS+ND2 CASE. 1 HOUR AND 30 MINUTES AFTER THE START OF SURGERY, WHILE THE ASSISTANT PHYSICIAN WAS CONTINUOUSLY INSERTING FORCEPS, COTTON BALLS, AND BALE GAUZE THROUGH THE GELPOIN MINI SLEEVE, THE ASSISTANT PHYSICIAN DISCOVERED THAT THE VALVE OF THE GELPOINT MINI SLEEVE HAD FALLEN OFF. THE GELSEAL CAP IS PIERCED WITH A [NAME] AIR SEAL (SMOKE EVACUATION DEVICE), AND AS FAR AS [NAME] COULD CONFIRM, THERE WAS NO INSERTION OR REMOVAL FROM THE DEVICE FROM HERE. THE VALVE WAS INTACT OR HAD FALLEN OUT, AND NO DAMAGE TO THE VALVE ITSELF COULD BE CONFIRMED. THE VALVE WAS RETRIEVED WITH FORCEPS FROM THE SLEEVE OF THE GELPOINT MINI AND THE PROCEDURE WAS CONTINUED. [NAME] ASKED THE ASSISTANT DOCTOR IF THERE WAS AN INSUFFLATION LEAK, AND HE SAID THERE WAS NO PROBLEM." PHOTOS HAVE BEEN PROVIDED. PRODUCT RETURN EXPECTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19NOV2021 FROM [NAME], APPLIED MEDICAL DIRECTOR, REGULATORY AFFAIRS AND QUALITY ASSURANCE. THE CLEAR SLEEVE VALVE FELL INTO THE PATIENT. "WHEN THE DOCTOR PUT THE SWAB IN THE SLEEVE, THE VALVE WAS ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965326 ↗
• MalfunctionOct 27, 2021Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: HYSTERECTOMY ABDOMINAL ROBOTIC XI. EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED BY MAIL. REPORT NUMBER (B)(4). GELPOINT MINI DEVICE WAS NOT HOLDING APPROPRIATE SEAL FOR CO2 GAS DURING ROBOTIC PROCEDURE. REMOVED THE GELSEAL CAP AND USED A NEW ONE. CO2 GAS SEAL WAS MAINTAINED WITH NEW DEVICE. PRODUCT NOT AVAILABLE FOR RETURN AS INDICATED BY MEDWATCH FORM. ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 14OCT2021 FROM [NAME]: PER THE REP, THE PHYSICIAN PLACED A TROCAR TOO CLOSE TO THE STOP COCK. CONFIRMED THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 15OCT2021 FROM [NAME]: THE LEAKING WAS NOTICED AT THE BEGINNING OF THE CASE ONCE THE INSUFFLATOR WAS TURNED ON. NO INSTRUMENTS WERE INSERTED DIRECTLY THROUGH THE GEL. IT WAS DETERMINED THAT THE TROCARS WERE PLACED TO CLOSE TO THE SMOKE EVACUATION PORT. THE PRODUCT WAS DISPOSED OF BY THE STAFF. TYPE OF INTERVENTION: A NEW GELSEAL CAP WAS USED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704473 ↗
• MalfunctionMar 25, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED SINGLE INCISION LAPARASCOPIC CHOLECYSTECTOMY. DETAILED DESCRIPTION OF EVENT: PRODUCT POUCH IS TORN. THE BLISTER PACKAGING WAS INTACT. CUSTOMER USED THE PRODUCTS IN A PROCEDURE. FROM CER FORM: WHEN OPENING THE INNER PACKAGING IT WAS RECOGNIZED THAT THE POUCH WAS ALREADY TORN. THE PARTS OF THE DEVICE WERE TAKEN OUT SEPARATELY OF THE PLASTIC BLISTER AND USED. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) BY EMAIL ON 06MAR2020: THE (B)(6) DISCUSSED THE CASE AGAIN WITH THE OPERATION ROOM MANAGER, WHO WAS QUITE SURE THAT THE POUCH WAS TORN AT THE MOMENT THEY WANTED TO OPEN IT. THEY DECIDED TO HAVE THE PRODUCT TAKEN OUT OF THE BLISTER BY THE STERILE NURSE. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) BY PHONE ON 04MAR2020: WITH "BLISTER PACKAGING", THE TRAY INSIDE THE POUCH IS MEANT. THE CUSTOMER USED THE PRODUCT BECAUSE THEY DID NOT REALIZE THAT THE TRAY IS NOT A STERILE BARRIER. PATIENT STATUS: FINE. TYPE OF INTERVENTION: N/I.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879317 ↗
• InjuryJun 7, 2019Device Fell

  CLEAR PLASTIC FELL APART AND INTO PT FROM GELPOINT MINI ADVANCED ACCESS PLATFORM. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8683765 ↗
• MalfunctionMay 31, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED NI. DETAILED DESCRIPTION OF EVENT: "HI [NAME]: JUST WANT TO LET YOU KNOW THAT I HAVE A MINI GELPOINT CAT# CNGL3 AT MY DESK FROM A CASE YESTERDAY WITH DR. [NAME]. APPARENTLY A PIECE OF IT FELL APART. I¿VE INCLUDED DR.[NAME] IN THE EMAIL ALSO IN CASE SHE HAS SOME INPUT ON THE SEQUENCE OF EVENTS. CAT# CNGL3 LOT# 1343048 EXPIRATION DATE 12/02/2021" ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 03MAY2019 FROM [NAME], APPLIED MED, ACCT. MGR. FROM DR. [NAME]. "IT WAS A CLEAR PLASTIC PART FROM THE PORT. IT WAS FREE FLOATING IN THE PATIENT'S ABDOMEN. I'M GLAD THAT MY PA NOTICED IT AND WE REMOVED IT. I WAS ABLE TO CONTINUE THE CASE OK." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 09MAY2019 FROM , APPLIED MED, ACCT. MGR.: "I HAD TO SEND THE PRODUCT TO OUR RISK MANAGEMENT DEPARTMENT. I¿M INCLUDING [NAME] SINCE I CAN¿T REMEMBER THE STAFF MEMBER IN RISK MANAGEMENT THAT IT GOT SENT TO. EITHER [NAME] OR MYSELF WILL FORWARD YOUR BELOW INFORMATION TO THEM SO THAT THEY CAN RETURN IT TO YOU AFTER THEIR NEEDS ARE MET." MEDWATCH 2000330000-2019-8032 RECEIVED VIA MAIL ON (B)(6) 2019: REPORTER: (B)(6). (B)(6) PATIENT INFO: 53 YRS, MALE, 81 KG, NOT HISPANIC/LATINO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660951 ↗
• MalfunctionNov 2, 2018Material Separation; Material Separation

  NAME OF PROCEDURE BEING PERFORMED: UNKNOWN AT THIS TIME. THE BAG AND THE RING COME OFF IN THE ABDOMINAL CAVITY. FURTHER DETAILS WILL FOLLOW. PICK UP ADDRESS WILL FOLLOW. PATIENT STATUS: UNKNOWN AT THIS TIME. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8035682 ↗
• MalfunctionJul 23, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. "THE GELPOINT MINI WAS PLACED AT THE BEGINNING OF THE PROCEDURE AND PLACED CORRECTLY (ALEXIS WASN'T ROLLED DOWN EXTREMELY TIGHT, TROCARS WERE INTRODUCED THROUGH THE GEL CAP BEFORE BEING PLACED ON THE ALEXIS). BOTH [SALES MANAGER] AND MYSELF WERE PRESENT AND SUPPORTING THE DEVICE IN THE CASE (ALONG WITH THE ALEXIS CONTAINED EXTRACTION SYSTEM). THE OTHER TROCARS (ADVANCED FIXATION AND Z-THREAD) WERE PLACED IN THE PATIENTS ABDOMEN ACCORDING TO SURGEON PREFERENCE. THE CASE STARTED AS NORMAL WITH INSUFFLATION ON ONE ON THE AF PORTS. THERE WERE 2 TROCARS (12MM AND 10MM) IN THE GELPOINT WHICH WERE UTILISED FOR THE SCOPE (10MM), HARMONIC, GYRUS BIPOLAR AND GRASPER. DURING THE LAPAROSCOPIC START OF THE CASE (BEFORE TISSUE EXTRACTION OR INTRODUCTION OF CONTAINMENT BAG) IT WAS NOTICED BY THE CONSULTANTS THAT THE GELPOINT MINI WAS QUITE LOOSE (NOT FIRM AGAINST THE ABDOMEN WHEN FIRST PLACED). [IT WAS] SUGGESTED THAT THE GEL CAP COULD BE REMOVED IN ORDER TO ROLL THE ALEXIS DOWN SOME MORE, WHICH WAS DONE AND THE CASE CONTINUED (IT WAS NOTED THAT THERE WAS MORE GAS BEING USED THAN USUAL). ONCE THE SPECIMEN WAS MOBILISED, THE ALEXIS CONTAINED EX

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713018 ↗
• MalfunctionJun 7, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: LAPAROSCOPIC CYSTECTOMY. EVENT DESCRIPTION: "SURGEON PLACED THE (B)(6) AND DURING THE SWEEP FOR BOWEL ENTRAPMENT THE PLASTIC SHEATH TORE. THE SURGEON DID NOT HAVE ANY SHARP OBJECTS NEARBY DURING THIS PROCESS." TYPE OF INTERVENTION: "THE PRODUCT WAS REMOVED AND DISPOSED OF." PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7580923 ↗
• MalfunctionJan 26, 2018Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: "ROBOTIC USO" EVENT DESCRIPTION: "PULLING OUT PIECES OF OMENTUM THROUGH THE TROCAR. THE SEAL CAME OUT OF TROCAR." TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7223466 ↗
• MalfunctionNov 21, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED -"LAPAROSCOPIC BILATERAL SALPINGECTOMY" "[SURGEON] CONDUCTING A LAPAROSCOPIC BILATERAL SALPINGECTOMY SINGLE SITE VIA GELPOINT MINI. I WAS NOT IN ATTENDANCE TO THE CASE. THE FASCIA WAS TAGGED PER THE PYSICIAN [SURGEON] PRIOR TO PLACING THE ALEXIS PORTION OF THE GELPOINT MINI. AFTER THE ALEXIS WAS RETRACTED DOWN AND GEL CAPPED PLACED ONTOP OF THE ALEXIS THERE WAS AN ATTEMPT TO ESTABLISH PNEUMOPERITENIUM. THEY WERE UNSUCCESFUL AT ESTABLISHING PNEUMOPERITENIUM. IT WAS MENTIONED THAT NO INSTRUMENTS OR LAPRASCOPE WERE PLACED DOWN ANY OF THE LOW PROFILE PORTS PRIOR TO THE REMOVAL OF THE GEL CAP. THE GEL CAP WAS REMOVED AND [SUREGEON] NOTICED THE PLASTIC SHEATH OF THE ALEXIS TO BE TORE. ALL OF THE PRODUCT WAS REMOVED FROM THE PATIENT AND SET ASIDE. ANOTHER GELPOINT MINI WAS OPENED AND USED WITH OUT ANY ISSUES."TYPE OF INTERVENTION -"ALL OF THE PRODUCT WAS REMOVED FROMTHE PATIENT AND SET ASIDE. ANOTHER GELPOINT MINI WAS OPENED AND USED WITH OUT ANY ISSUES."PATIENT STATUS -NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049758 ↗