GelPort® Hand Access Laparoscopic System C8XX2Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00607915118303), received between Jan 26, 2016 and Apr 17, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (17 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: INFORMATION PROVIDED BY [NAME] ON 30MAR2026: I AM [NAME]. I AM THE UROLOGY LEAD IN ST AT [FACILITY]. I HAVE A LAPAROSCOPIC HAND ASSIST PORT THAT HAD A HAIR INSIDE. WE WOULD LIKE TO GET IT REPLACED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 01APR2026: I HAVE IT WITH ME. I CAN GIVE TO [NAME] - SHE WILL BE RECEIVING THE REPLACEMENT AND WILL SEND THIS OUT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 13APR2026: THE TIMING OF THE EVENT WAS RIGHT WHEN WE OPENED THE PACKAGE TO THE STERILE FIELD. [NAME] HAS THE PACKAGE WHICH SHOULD HAVE THE LOT # TYPE OF INTERVENTION: NA (BEFORE USE). PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916847 ↗
• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPE, GENERAL & PLASTIC SURGERY. EVENT DESCRIPTION: [FROM FDA REPORT MW5179559]. SITUATION: IT WAS DURING THE CLOSING COUNT WHEN THE SCRUB TECHNICIAN NOTICED THAT THE POLYURETHANE OF THE WOUND PROTECTOR FROM THE GELPORT WAS TORN. THE SURGEON WAS INFORMED IMMEDIATELY. THE SURGEON PERFORMED A WOUND CHECK AND USED THE ENDOSCOPE TO EXAMINE INTRAABDOMINALLY. NO RETAINED OBJECT WAS FOUND. BACKGROUND THE GELPORT CONTAINS 3 PIECES: THE GELSEAL CAP, THE ALEXIS O WOUND PROTECTOR AND THE RETENTION RING. THE GELPORT WAS USED DURING MINIMAL INVASIVE SURGERY FOR UNLIMITED TROCAR INSERTION AND INSTRUMENT OR HAND EXCHANGES WHILE MAINTAINING PNEUMOPERITONEUM. ASSESSMENT THE ALEXIS O WOUND PROTECTOR CONSISTS OF THE WHITE RING AND POLYURETHANE SURROUND TO PROTECT THE WOUND. DURING REPEATED INSTRUMENT EXCHANGES, THE POLYURETHANE WOULD TEAR. THE TEAM FOLLOWED THE POLICY TO INFORM THE SURGERY. THE SURGEON STATED THAT HE HAD EXAMINED THE WOUND AND INSIDE THE ABDOMEN AND DID NOT FIND ANY FRAGMENT OF THE POLYURETHANE. THE TEAM ALSO WENT ABOVE TO HAVE X-RAY ON THE ABDOMEN AND REPORTED NO FOREIGN OBJECTS. RECOMMENDATION HUDDLE WITH TEAM ON THE TEAM REGARDING THE POTENTIAL FOR THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873715 ↗
• MalfunctionAug 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ESOPHAGECTOMY. EVENT DESCRIPTION: WHEN CONVERSION REQUIRED REMOVAL OF THE GELPORT, IT WAS THEN NOTICED THAT THE SHEATH WAS TORN. THE TEAR WAS NOT OBSERVED DURING USE. DURING THE PROCEDURE, THE GELPORT WAS REMOVED DUE TO CONVERSION. UPON REMOVAL, IT WAS OBSERVED THAT THE ALEXIS SHEATH WAS TORN. THE TEAR WAS NOT NOTICED DURING USE AND HAD NO EFFECT ON THE PROCEDURE. INTERVENTION: UNKNOWN. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904898 ↗
• MalfunctionOct 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP HAND ASSIST COLON RESECTION. EVENT DESCRIPTION: C8XX2 MALFUNCTIONED. ADDITIONAL INFORMATION RECEIVED ON 27SEP2022 VIA EMAIL FROM [NAME], MATERIALS MANAGER: "RIPPED WHILE USING." NO INJURIES RELATED TO THE REPORTED CONCERN. ADDITIONAL INFORMATION RECEIVED ON 28SEP2022 VIA EMAIL FROM [NAME], MATERIALS MANAGER.: THE ALEXIS SHEATH TORE. THE SURGEON'S HAND WAS CUPPED APPROPRIATELY AND INSERTED INTO THE DEVICE AT THE TIME OF TEAR. THE ALEXIS SHEATH WAS TORN FROM WHITE TO GREEN ALL THE WAY THROUGH. THE SURGEON REMOVED TORN SHEATH AND OPENED ANOTHER SHEATH TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 29SEP2022 VIA EMAIL FROM [NAME]: PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO INJURIES RELATED TO THE REPORTED CONCERN. TYPE OF INTERVENTION: THE SURGEON REMOVED TORN SHEATH AND OPENED ANOTHER SHEATH TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583656 ↗
• MalfunctionOct 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: KT DONOR EVENT DESCRIPTION: [NAME] MEDICAL CENTER. THE DEVICE WAS BEING USED FOR KT DONOR. NO EXTERNAL PHYSICAL FORCE WAS APPLIED TO THE DEVICE DURING THE SURGERY, BUT THE FILM ATTACHED TO ALEXIS' WHITE RING WAS TORN. THE GAS LEAKED, SO IT WAS REPLACED WITH A NEW DEVICE. THERE WAS NO HEALTH CHANGE. THE CASE WAS COMPLETED WITH A NEW DEVICE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 04OCT2022 FROM [NAME], RA/QA SPECIALIST [FACILITY]. "PRODUCT WAS TORN WHILE IT WAS BEING USED TO PATIENT. THE PRODUCT WAS REMOVED AND REPLACED WITH NEW ONE. SURGEON'S HAND WAS INSERTED INTO THE DEVICE. THE TEAR DID NOT OCCUR DURING REMOVAL." THE SHEATH TORE NEAR THE WHITE OUTER RING. THERE WERE NO TROCARS/INSTRUMENTS PLACED DIRECTLY THROUGH THE GELPORT. THERE WAS NO ANASTOMOSIS. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547585 ↗
• MalfunctionApr 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: KIDNEY TRANSPLANT. EVENT DESCRIPTION: THE PROFESSOR [NAME] OF MEDICAL CENTER USED THE DEVICE FOR THE KIDNEY TRANSPLANT. THE VINYL PART OF THE PRODUCT WAS TORN. THERE WAS NO HEALTH CHANGE. THE SURGERY WAS REPLACED WITH A NEW DEVICE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 14APR2022 FROM APPLIED MEDICAL OPERATION SUPERVISOR: THE TEAR OCCURRED AT THE BEGINNING OF THE PROCESSER. THE NURSE FOUND THAT THE VINYL OF ALEXIS WAS TORN, SO THE RING PART OF THE GELPORT DID NOT JOIN TOGETHER WITH ALEXIS. NO TROCARS/INSTRUMENTS WERE PLACED DIRECTLY THROUGH THE GELPORT. THE GELSEAL CAP REMOVED TO PERFORM ANASTOMOSIS. NO IMAGES ARE AVAILABLE BECAUSE THE TORN ALEXIS WAS THROWN AWAY BY NURSE WHEN THEY FOUND THE PRODUCT'S FLAW. TYPE OF INTERVENTION: THE SURGERY WAS REPLACED WITH A NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221824 ↗
• MalfunctionApr 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PROCEDURE PERFORMED: LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. COMPLAINT 1 OF 2: #2022-000889 (MFR # 2027111-2022-00542). COMPLAINT 1 OF 2: #2022-000890. EVENT DESCRIPTION: "IN BOTH CASES THE GELPORT CAP AND ATTACHED ALEXIS CAME OUT OF THE INCISION WHEN THE SURGEON ATTEMPTED TO REMOVED HIS HAND THROUGH THE CAP. IN THE FIRST CASE, THIS HAPPENED TWICE. IN THE SECOND CASE, THIS HAPPENED ONCE. THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. BOTH CASES CONTINUED WITH THE SAME DEVICE... NO OTHER INSTRUMENTS WERE BEING USED THROUGH THE GEL AT THE TIME OF THE EVENT. THE MODEL OF THE GELPORT IS C8XX2 (P/N 700314663), LOT NUMBER 1433372. NO PRODUCT IS AVAILABLE FOR RETURN. BOTH GELPORTS WERE BROUGHT IN UNDER A NO CHARGE SCRUB PO." BOTH CASES WERE A LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 25MAR2022 FROM [NAME], ASSOCIATE CLINICAL SPECIALIST: THE PRODUCTS WERE DISPOSED OF BEFORE AMR WAS MADE AWARE OF THE INCIDENTS. ALERT DATE IS 21MAR2022. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. TYPE OF INTERVENTION: THE CASE CONTINUED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079009 ↗
• MalfunctionApr 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PROCEDURE PERFORMED: LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. COMPLAINT 1 OF 2: #2022-000889. COMPLAINT 1 OF 2: #2022-000890. EVENT DESCRIPTION: "IN BOTH CASES THE GELPORT CAP AND ATTACHED ALEXIS CAME OUT OF THE INCISION WHEN THE SURGEON ATTEMPTED TO REMOVED HIS HAND THROUGH THE CAP. IN THE FIRST CASE, THIS HAPPENED TWICE. IN THE SECOND CASE, THIS HAPPENED ONCE. THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. BOTH CASES CONTINUED WITH THE SAME DEVICE... NO OTHER INSTRUMENTS WERE BEING USED THROUGH THE GEL AT THE TIME OF THE EVENT. THE MODEL OF THE GELPORT IS C8XX2 (P/N 700314663), LOT NUMBER 1433372. NO PRODUCT IS AVAILABLE FOR RETURN. BOTH GELPORTS WERE BROUGHT IN UNDER A NO CHARGE SCRUB PO." BOTH CASES WERE A LAPAROSCOPIC HAND ASSISTED SIGMOIDECTOMY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 25MAR2022 FROM [NAME], ASSOCIATE CLINICAL SPECIALIST: THE PRODUCTS WERE DISPOSED OF BEFORE AMR WAS MADE AWARE OF THE INCIDENTS. ALERT DATE IS 21MAR2022. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY, CURRENT PATIENT STATUS UNKNOWN. TYPE OF INTERVENTION: THE CASE CONTINUED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048127 ↗
• MalfunctionDec 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: RESECTION LEFT COLON - LAPAROSCOPIC. EVENT DESCRIPTION: COMPLAINT BASED ON MEDWATCH REPORT #(B)(4). MEDWATCH RECEIVED ON 22NOV2021 VIA MAIL. "GELPORT WAS BEING USED BY THE PHYSICIAN FOR THE SURGICAL PROCEDURE. SURGEON NOTED THAT GAS WAS ESCAPING THE ABDOMEN, BUT IT WAS NOT APPARENT WHERE THE GAS WAS LEAKING. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THERE WAS TEAR IN THE DEVICE CAUSING THE GAS TO LEAK AND DEFLATING THE ABDOMEN. THE GELPORT WAS REMOVED FROM THE SURGICAL FIELD AND REPLACED. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION- THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO". PRODUCT AVAILABLE FOR RETURN AS INDICATED IN THE MW REPORT. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 09DEC2021 FROM [NAME] HOSPITAL COULD NOT FIND THE DEVICE, PRODUCT NO LONGER RETURNING. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED WITHIN THE DESCRIPTION OF THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019279 ↗
• MalfunctionAug 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  DETAILED DESCRIPTION OF EVENT: HOSPITAL: [NAME]. "AFTER A FEW MINUTES, THE AIR LEAKAGE OCCURRED FROM THIS DEVICE BECAUSE THE WOUND SHEATH IS INCOMPLETE ATTACHED THE GREEN RING. PLEASE CONSULT WITH PHOTO." PRODUCT RETURN EXPECTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08JUN2021 FROM [NAME]: THE SURGICAL STAFF DID NOT NOTICE THE WHITE RING BREAK SHOWN IN THE PICTURE. THE PROBLEM THE SURGEON ENCOUNTERED WAS THAT THEY COULD NOT ESTABLISH PNEUMOPERITONEUM IN SURGERY. NO INSTRUMENTS WERE USED THROUGH THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. PATIENT STATUS: "FINE." TYPE OF INTERVENTION: A NEW DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285284 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED BY MAUDE SEARCH. REPORT NUMBER (B)(4). "GEL PORT WAS IN THE INCISION ON PATIENT'S ABDOMEN. DOCTOR PUT HIS HAND THROUGH THE PORT AND THE FILM INSIDE DETACHED FROM THE RING. UPON INSPECTION, IT DOES NOT APPEAR ANY OF THE FILM FROM THE PORT WAS MISSING." DEVICE NOT AVAILABLE FOR RETURN. THIS IS AN ANONYMOUS COMPLAINT FILED BY AN UNKNOWN REPORTER VIA MAUDE. THUS, NO FURTHER INFORMATION CAN BE OBTAINED. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED WITHIN THE DESCRIPTION OF THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088725 ↗
• MalfunctionApr 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED MILES PROCEDURE [NAME] HOSPITAL "AFTER THE PATIENT SETUP WAS COMPLETE, THE ALEXIS SHEATH TORN WHEN THE DOCTOR INSERTED HIS HAND INTO THE GEL SEAL CAP THEN PULLED IT OUT. NEW PACKAGE WAS OPENED AND PROCEDURE WAS COMPLETED. THIS SURGEON PERFORMS HALS A LOT AND HAS BEEN DOING 10 CASES IN LAST 2 MONTHS." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2021 FROM [NAME]: "I CHECKED THE INFORMATION AND I THOUGHT THIS ISSUE HAS BEEN OCCURRED BECAUSE THE PHYSICIAN'S HAND CONTACTED WITH THE SHEATH AND THE SHEATH HAD AN EXCESSIVE LOAD. THEREFORE, I THINK THIS ISSUE IS NOT A DEVICE RELATED EVENT. IN ANY CASE, SINCE THERE WAS NO HEALTH DAMAGE TO THE PATIENT AND NO INFORMATION INDICATING THE SERIOUS SITUATION I DECIDED I DO NOT REPORT THIS EVENT TO PMDA." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2021 FROM [NAME]: "THE TEAR OCCURRED NEAR THE GREEN RING AND NO INSTRUMENTS WERE INSERTED INTO THE GEL." PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653841 ↗
• MalfunctionFeb 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: LAP NEPHRECTOMY DETAILED DESCRIPTION OF EVENT: THE PLASTIC PORTION OF THAT CONNECTS THE TOP TO THE BOTTOM DISCONNECTED. OPENED ANOTHER GELPORT TO CONTINUE THE CASE. IT IS UNKNOWN AT WHAT POINT IN THE CASE THE DISCONNECTION OCCURRED. THERE WAS NO PATIENT INJURY. PHOTOS TO BE PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY TYPE OF INTERVENTION OPENED A NEW GELPORT AND CONTINUED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369322 ↗
• MalfunctionDec 3, 2020Material Separation; Material Separation

  NAME OF PROCEDURE PERFORMED: LAP COLECTOMY. THE REP WAS NOT PRESENT DURING THE CASE. DURING THE CASE THE SURGEON WAS PULLING ON THE ALEXIS AND IT TORE IN TWO. LOCATION OF THE DAMAGE IS UNKNOWN. IT IS UNKNOWN IF ANY INSTRUMENTATION CAME IN DIRECT CONTACT WITH THE ALEXIS. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: NI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10942992 ↗
• MalfunctionOct 14, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED LAPAROSCOPIC SIGMOID HAND-ASSISTED COLON RESECTION DETAILED DESCRIPTION OF EVENT: LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. "GEL PLASTIC WOUND PROTECTOR PART THAT GOES INSIDE THE PATIENT RIPPED AND COMPLETELY BROKE OFF FROM THE RING WHILE INSUFFLATED INSIDE THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2020 FROM [NAME]: NO PATIENT INJURY OCCURRED. PATIENT IS FINE. THE TEAR OCCURRED 1-2 HRS INTO THE PROCEDURE. THE SHEATH TORE IN ONE PIECE TEAR ALL HANGING OFF TOGETHER, NO PIECES. GRASPERS WERE BEING USED AT THE TIME, NO WHERE NEAR HANDPORT. TROCARS AND INSTRUMENTS WERE NOT PLACED DIRECTLY THROUGH THE GELPORT. PATIENT STATUS: FINE TYPE OF INTERVENTION: ANP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677899 ↗
• MalfunctionAug 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: LEFT HAND-ASSISTED NEPHRECTOMY. DETAILED DESCRIPTION OF EVENT: DURING THE CASE, THE ALEXIS SHEATH WAS FIRST DEPLOYED WITHIN THE INCISION. THE GEL CAP WAS PLACED OVER THE ALEXIS AND A 5MM [NAME] TROCAR WAS USED THROUGH THE CAP FOR ABOUT 30 MINUTES. AT THAT POINT THE PROCEDURE WAS SWITCHED TO OPEN AND THE GEL SEAL CAP WAS REMOVED. WHEN THE CAP WAS REMOVED, THE SHEATH FELL AWAY FROM THE RING AND THE ALEXIS WAS NO LONGER ABLE TO PROVIDE RETRACTION AT THE INCISION SITE. THE DEVICE DID NOT FRAGMENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW ALEXIS WAS OPENED TO PROVIDE RETRACTION AND COMPLETE THE CASE. NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 03AUG2020 FROM [NAME] : PHOTOS HAVE BEEN PROVIDED OF THE DEVICE PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 12AUG2020 FROM [NAME]: "UNFORTUNATELY, MY CONTACT [NAME] GENERAL SERVICE LEAD DID NOT REMEMBER WHICH RING THE SHEATH SEPARATED FROM. THE ONLY PICTURE THAT SHE TOOK WAS THE OUTSIDE OF THE BOX SAME ONE THAT I PROVIDED TO YOU WITH THE LOT NUMBER. I DID CONFIRM THE INNER RING WAS ABLE TO BE PULLED OUT OF INCISION LIKE IT TYPICALLY WOUL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420834 ↗
• MalfunctionFeb 12, 2020Material Separation; Material Separation

  NAME OF PROCEDURE BEING PERFORMED: NI. DETAILED DESCRIPTION OF EVENT: "GELPORT FOR LAPAROSCOPIC ASSIST HAD A TEAR IN THE SEAL." PATIENT STATUS: "NO" ADVERSE EVENT. TYPE OF INTERVENTION: NI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703499 ↗
• MalfunctionDec 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSOCPIC LEFT COLECTOMY. DETAILED DESCRIPTION OF EVENT: FROM MEDWATCH # (B)(4). THIS EVENT OCCURRED IN (B)(6) 2019. EVENT DESCRIPTION: "THE GELPORT RIPPED DURING USAGE; SEPARATING THE TWO RINGS. THERE WAS NO HARM NOR PRODUCT RETAINED IN THE PATIENT. UNFORTUNATELY, THIS IS ALL THE INFORMATION REGARDING THIS INCIDENT." REGARDING THE ORIGINAL INTENDED PROCEDURE, THE GELPORT WAS BEING PLACED IN THE ABDOMEN TO ACHIEVE PNEUMOPERITONEUM. 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. THERE IS NO OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM [NAME] RISK MANAGER AT [NAME] VIA E-MAIL ON JANUARY 10TH, 2020: "I APOLOGIZE THAT IT HAS TAKEN ME A COUPLE MONTHS TO GET BACK TO YOU. I ACTUALLY HAVE THIS PRODUCT, AND CAN RETURN IT TO YOU, IF YOU PROVIDE A RETURN KIT. PLEASE SEND IT TO: [NAME] (B)(6) . THE DATE OF THIS EVENT WAS (B)(6) 2019. THE PATIENT WAS HAVING A LAPAROSCOPIC LEFT COLECTOMY. THE CASE WAS CONTINUED ONCE A NEW GELPORT WAS OBTAINED AND PLACED. TWO 5 MM TROCARS WER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9420579 ↗
• MalfunctionSep 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: HAND ASSISTED LAPAROSCOPIC SIGMOID COLECTOMY WITH A PFANNENSTIEL INCISION. DETAILED DESCRIPTION OF EVENT: SURGEON: DR. [NAME]. COMPLAINT: THE SHEATH ON THE ALEXIS RETRACTOR ON THE GELPORT BROKE. A PICTURE IS ATTACHED. CUSTOMER WOULD LIKE A CREDIT FOR ONE GELPORT AND HAS THE PRODUCT AVAILABLE TO SHIP BACK BUT THEY THREW AWAY PACKAGING AND DO NOT KNOW LOT NUMBER. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER, VIA E-MAIL ON AUGUST 14TH, 2019: I WAS NOT PRESENT FOR THE CASE. NO PATIENT INJURY OR ILLNESS. PATIENT WAS FINE. DON¿T KNOW PATIENT DEMOGRAPHICS, SURGEON SAID IT WAS A STRAIGHTFORWARD CASE THAT WAS NOTHING SPECIAL. ANOTHER GELPORT WAS OPENED AND CASE COMPLETED AFTER FIRST GELPORT ALEXIS SHEATH BROKE. ONLY THE HAND WAS PLACED THROUGH THE GELPORT. TEAR OCCURRED WHEN SURGEON REMOVED HIS HAND DURING THE PROCEDURE. TEAR OCCURRED DURING THE PROCEDURE AND NOT UPON PLACEMENT. DEVICE WAS REMOVED AND REPLACED CASE WAS A HAND ASSISTED LAPAROSCOPIC SIGMOID COLECTOMY WITH A PFANNENSTIEL INCISION. PATIENT STATUS: PATIENT WAS FINE. TYPE OF INTERVENTION: ANOTHER GELPORT WAS OPENED AND CASE COMPLETED AFTER FIRST GELPORT ALEXIS SHEATH BROK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8961144 ↗
• MalfunctionMay 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED LAP HAND ASSISTED DONOR NEPHRECTOMY. DETAILED DESCRIPTION OF EVENT: ¿DURING PROCEDURE THE HAND ENTRY TORE. THEY WOULD LIKE AN INVESTIGATION TO BE COMPLETED. THEY DO HAVE THE SAMPLE FOR RETURN. LIMITED INFORMATION AVAILABLE". ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM ACCOUNT MANAGER ASSOCIATE, ON TUESDAY, 16APR2019: PROCEDURE WAS LAP HAND ASSISTED DONOR NEPHRECTOMY. THE DEVICE WAS REMOVED, ANOTHER ONE OPENED. THE PROCEDURE WAS COMPLETED. THE SURGEON'S HAND WAS NOT INSERTED INTO THE DEVICE AT THE TIME OF THE GEL SEPARATION. THE GELSEAL CAP AND THE SURGEON'S HAND WAS LUBRICATED PRIOR TO HAND ACCESS. THE GEL STARTED TO DETACH IMMEDIATELY WHEN THE DEVICE WAS IN USE. ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE FROM ACCOUNT MANAGER ASSOCIATE, ON TUESDAY, 30APR2019: THE CORRECT PRODUCT WAS RETURNED. THE ISSUE IS NOT WITH THE GEL BUT WITH THE ALEXIS SHEATH TORN. TYPE OF INTERVENTION: DEVICE REMOVED, ANOTHER ONE OPENED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591262 ↗
• MalfunctionNov 29, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PROCEDURE PERFORMED: LAPAROSCOPIC LOW ANTERIOR COLON RESECTION WITH HANDSEWN COLONAL ANASTOMOSIS EVENT DESCRIPTION: MEDWATCH REPORT # 2600320000-2018-8124 RECEIVED FROM THE FDA VIA MAIL ON (B)(6) 2018. WHILE USING THE GELPORT LAPAROSCOPIC SYSTEM THE PHYSICIANS NOTICED THAT THE PNEUMO WAS NOT STAYING AT THE LEVEL THAT IS SHOULD BE AND KEPT DROPPING MAKING IT DIFFICULT TO OPERATE. THEY STARTED LOOKING AT INSTRUMENTS AND PORTS TO DETERMINE IF THERE WAS A LEAK SOMEWHERE AND IT WAS AT THIS TIME THAT THEY NOTICED THAT THE GELPORT HAS A HOLE IN IT AND WAS CAUSING THEM TO LOSE PNEUMO. THE GELPORT WITH THE HOLE IN IT WAS REMOVED AND REPLACED WITH A NEW GELPORT THAT WAS FUNCTIONING PROPERLY AND CONTINUED THE SURGERY WITHOUT FURTHER INCIDENT. DATE OF EVENT: (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2018 FROM HOSPITAL PROJECT COORDINATOR: "THERE WAS NO HARM TO PATIENT. THE EVENT DATE WAS (B)(6) 2018. IT IS UNKNOWN IF TROCARS WERE PLACED THROUGH THE GELPORT. IT IS UNKNOWN IF INSTRUMENTS WERE PLACED DIRECTLY THROUGH THE GELPORT." PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115485 ↗
• MalfunctionOct 10, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: HAND ASSIST LAPAROSCOPIC LEFT HEMICOLECTOMY ALEXIS WOUND PROTECTOR WAS TORN DURING PROCEDURE WHEN SURGEONS HAND WAS INSERTED IN THE GELPORT. WHEN SURGEON REMOVED HAND, ALEXIS WAS ALSO REMOVED FROM PATIENT AND GREEN RING WAS ATTACHED TO UPPER RETRACTION RING WITH SMALL STRIP OF CLEAR PLASTIC MATERIAL. I HAVE ASKED CUSTOMER TO RETAIN PRODUCT. HAPPENED APPROXIMATELY ONE HOUR AFTER PROCEDURE BEGAN. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON (B)(6) 2018 FROM ACCOUNT MANAGER: NO PATIENT INJURY. WHEN HAND WAS THROUGH GEL, NOTICED A LOSS OF PNEUMO. GELPORT AND ALEXIS REMOVED AND GREEN RING OF ALEXIS WAS DANGLING BY ONE STRIP OF PLASTIC. PLACED NEW GELPORT AND COMPLETED CASE. TYPE OF INTERVENTION: PLACED NEW GELPORT AND COMPLETED CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954587 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: COLON SURGERY. MEDWATCH RECEIVED VIA MAIL ON 07AUG2018: MW5078577: MD WAS USING A WOUND RETRACTOR FOR HAND ASSISTED COLON SURGERY. THE LOWER RING BECAME DETACHED FROM THE UPPER RING INSIDE OF THE PATIENT'S ABDOMEN. ALL PARTS WERE REMOVED FROM THE PATIENT. RECEIVED ADDITIONAL INFORMATION VIA EMAIL ON 08AUG2018 FROM REGIONAL RISK MANAGEMENT SPECIALIST: THERE WAS NO HARM TO THE PATIENT. ALL PIECES WERE ABLE TO BE RETRIENVED FORM THE ABDOMEN. I DO HAVE THE DEVICE AVAILABLE FOR RETURN. PATIENT STATUS: NO HARM TO PATIENT. TYPE OF INTERVENTION: UNKNOWN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848875 ↗
• MalfunctionApr 6, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: LAPAROSCOPIC LIVER RESECTION "LAP HAND ASSISTED COLECTOMY" EVENT DESCRIPTION: "THE WOUND PROTECTOR PIECE OF THE APPLIANCE COMPLETELY CAME APART" ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON APRIL 04, 2018 FROM APPLIED MEDICAL ACCOUNT MANAGER: "I WAS ABLE TO FIND OUT FURTHER INFORMATION ON WHAT HAPPENED THROUGH HIS SURGICAL ASSISTANT, PA. FIRST AND FOREMOST, THERE WAS NO HARM TO THE PATIENT AND THEY SEARCHED THROUGH THE ABDOMEN WITH NO FINDINGS OF ANY SHEATH FRAGMENTS. APPROXIMATELY 30-40 MINUTES INTO THE LAP HAND ASSISTED COLECTOMY, WHEN THE SURGEON PULLED HIS HAND OUT OF THE GELPORT, THE ALEXIS PORTION "DISINTEGRATED" AND CAME COMPLETELY APART. I INQUIRED ABOUT IF IT WAS A FRAGMENT TEAR OR STRETCH TEAR AND SHE NOTED IT WAS MORE OF A FRAGMENTATION. IT TORE AT THE TOP OF THE SHEATH OF THE CURRENTLY ROLLED DOWN ALEXIS WHERE THE SHEATH MET THE TOP RING (ABOUT HALF WAY DOWN THE SHEATH IF YOU WERE TO UNROLL THE ALEXIS). THIS WAS A STANDARD PROCEDURE WHERE NOTHING OUT OF THE ORDINARY WAS BEING PERFORMED OR ATTEMPTED AND BOTH THE SURGEON AND STAFF ARE VERY PROFICIENT IN USING THE GELPORT AND ALEXIS. THERE WERE NO INSTRUMENTS OR TROCARS PLACED THROUGH THE GEL OF THE AL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405396 ↗
• MalfunctionMar 15, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: "[SURGEON] WAS IN A CASE AND HAD AN INCIDENT WITH 2 PORTS. THE PLASTIC LET GO OF THE RING. THE SURGEON OPENED A THIRD ONE AND IT DID NOT TEAR." TYPE OF INTERVENTION: "THE SURGEON OPENED A THIRD ONE AND IT DID NOT TEAR." PATIENT STATUS: UNK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7343913 ↗