AIRSEAL IAS12-120LPIRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10845854045688), received between Dec 15, 2020 and Nov 26, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 14, 2026Class IIOpen, Classified

   Potential for overpressure alerts.

   Z-2473-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE IAS12-120LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS BEING USED DURING A ROBOTIC PROCEDURE ON 06NOV25 WHEN IT WAS REPORTED ¿DURING THE ROBOTIC PROCEDURE, THE AIRSEAL VALVE GRADUALLY DETERIORATED, EVENTUALLY LEADING TO ONE OF THE FOUR VALVES DETACHING AND FALLING INTO THE PATIENT. NEED TO USE ADDITIONAL EQUIPMENT AND INSTRUMENTS IN ORDER TO SUCCESSFULLY LOCATE THE VALVE IN THE PATIENT'S THORAX.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655399 ↗
• InjuryMay 1, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-120LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN A ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY WITH COLOSTOMY CREATION PROCEDURE ON (B)(6) 2025, AND ¿THE TROCAR TIP WAS BROKEN OFF DURING PROCEDURE¿. FURTHER ASSESSMENT FOUND THE DEVICE HAD FRAGMENTED INTO THE PATIENT AND "ONLY PORTION WAS RETRIEVED.... UNABLE TO FIND OTHER PORTION". THE RETRIEVED FRAGMENT WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED AS NORMAL, WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH NO DELAY. THE PATIENT WAS REPORTEDLY NOT INJURED. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT DUE TO THE EVENT. THE PATIENT'S CURRENT STATUS IS DESCRIBED AS "INPATIENT SPINAL CORD INJURY UNIT". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A PORTION OF THE DEVICE MISSING AFTER FRAGMENTATION INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21941459 ↗
• MalfunctionDec 16, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE IAS12-120LPI, 12 MM ACCESS PORT & PALM GRIP OBTURATOR WAS BEING USED ON APPROXIMATELY (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿WE HAD THIS TROCAR THAT WAS DEFECTIVE IN A CASE. A PIECE BROKE OFF FROM THE DISTAL END OF THE TROCAR. THEY WERE ABLE TO RETRIEVE THE PIECE". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940503 ↗
• InjurySep 23, 2024Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER MW5157585 ON (B)(6) 2024. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST AN IAS12-120LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE. THE DATE OF THE PROCEDURE WAS NOT LISTED. THE REPORTER REMAINED ANONYMOUS. THE REPORT STATES, ¿WHILE PERFORMING A ROBOTIC ASSISTED LAPAROSCOPIC RIGHT RADICAL NEPHRECTOMY. TOWARDS THE END OF THE PROCEDURE, WHEN REMOVING LAPAROSCOPIC ACCESS PORTS THE AIRSEAL ACCESS PORT (REF# IAS12-120LPI) BROKE APART INSIDE OF THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. HOWEVER, IT IS UNKNOWN IF ALL FRAGMENTATION WAS RETRIEVED FROM PATIENT. DUE TO THE REPORTER BEING ANONYMOUS CONMED IS UNABLE TO REQUEST FURTHER INFORMATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF DEVICE FRAGMENTATION WITHOUT KNOWLEDGE OF RETRIEVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20277653 ↗
• MalfunctionJul 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER 19475324 ON (B)(6) 2024. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST AN IAS12-120LPI, AIRSEAL 12/120MM LPI PORT DEVICE. THE DATE OF THE PROCEDURE WAS LISTED AS (B)(6) 2024. THE REPORTER REMAINED ANONYMOUS. THE REPORT STATES, ¿DURING AN A DAVINCI XI RADICAL PROSTATECTOMY PROCEDURE IN NPOR 4, THE BLUE PART OF THE AIRSEAL TOP BROKE OFF AND FELL INTO THE PATIENT. THE PA ASSISTING WAS ABLE TO RETRIEVE BOTH BLUE BROKEN PIECES FROM INSIDE THE PATIENT. NO HARM REACHED THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE ARE NO OTHER DETAILS FOR CONMED TO INVESTIGATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860604 ↗
• MalfunctionJul 24, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT WAS BEING USED ON (B)(6) 2024 DURING A PROSTATECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THE BLUE PLASTIC VALVES ON THE WHITE SOUND CAP FOR THE 12MM AIRSEAL ACCESS PORT BROKE OFF AND FELL THROUGH THE CANNULA INTO THE PATIENT'S ABDOMEN. IT WAS REMOVED FROM THE PATIENT'S ABDOMINAL CAVITY AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817608 ↗
• MalfunctionMay 6, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT DEVICE WAS BEING USED DURING A ROBOTIC ASSISTED LAPAROSCOPIC CYSTECTOMY PROCEDURE ON 22APR24, AND THE ¿AIRSEAL TROCAR CAP PIECES FELL INSIDE THE PERITONEUM/BODY CAVITY. THEY WERE ABLE TO RETRIEVE THE ITEM OUT OF THE ABDOMEN AND DID NOT CAUSE PATIENT HARM. THE SURGEON BELIEVES IT WAS A PIECE OF THE AIRSEAL CAP AND DESCRIBED IT AS A BLUE PIECE.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO DELAY WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250243 ↗
• MalfunctionJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT 4900240000-2023-8131, RECEIVED FROM THE FDA ON FRIDAY, 15DEC23, WHEREIN THE CUSTOMER REPORTED THAT THE DEVICE, IAS12-120LPI, AIRSEAL 12/120MM LPI PORT, WAS USED IN A THORACOSCOPY, W/ LOBECTOMY TOTAL OR SEGMENTAL W/ DA VINCI PROCEDURE ON (B)(6) 2023, AND ¿FOUR ROLLED RAYTEC SPONGES INSERTED THROUGH PORT BY ASSISTING PA FOR SURGEONS USE WITH ROBOTIC ARMS INSIDE PATIENT. SURGEON NOTED BLUE TRIANGULAR PIECE OF SILICONE INSIDE PATIENT¿. FOLLOW-UP ASSESSMENT FOUND THAT ALL COMPONENTS WERE REMOVED FROM THE PATIENT SURGICAL SITE WITH THE USE OF A LAP GRASPER. THERE WAS NO REPORT OF DELAY, IMPACT, INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427152 ↗
• MalfunctionDec 13, 2023

  FOUR ROLLED RAYTEC SPONGES INSERTED THROUGH PORT BY ASSISTING PA FOR SURGEONS USE WITH ROBOTIC ARMS INSIDE PATIENT. SURGEON NOTED BLUE TRIANGULAR PIECE OF SILICONE INSIDE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18323517 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT IAS12-120LPI, AIRSEAL 12/120MM LPI PORT DEVICE WAS BEING USED DURING A ROBOT-ASSISTED NEPHRECTOMY PROCEDURE POST OPERATIVELY ON (B)(6) 2023 WHEN IT WAS REPORTED ¿SUBCUTANEOUS EMPHYSEMA OCCURRED, ALTHOUGH THE CAUSAL RELATIONSHIP WITH THE PRODUCT IS UNKNOWN. THE PATIENT WAS NOT REQUIRED TO UNDERGO ANY ADDITIONAL TREATMENT, AND THE PATIENT WAS MERELY OBSERVED. THE CONFIRMED EVENT WAS THAT GAS LEAKAGE OCCURRED DURING THE SURGERY, AND PNEUMOPERITONEUM COULD NOT BE MAINTAINED. AFTER REPLACING THE TROCAR AND TUBE, PNEUMOPERITONEUM WAS RESTARTED. AFTER THE SURGERY, DOCTORS NOTICED THAT SHE HAD DEVELOPED SUBCUTANEOUS EMPHYSEMA. THE PRESENCE OR ABSENCE OF PRODUCT DEFECTS AND THE CAUSAL RELATIONSHIP ARE UNKNOWN. THE FACILITY BELIEVES THAT IF THERE IS A HOLE SOMEWHERE IN THE TROCAR, IT COULD LEAD TO SUBCUTANEOUS EMPHYSEMA FROM THE ABDOMINAL WALL, SO THE ACTUAL ITEM NEEDS TO BE INSPECTED AND REPORTED.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE DEVICE ASM-EVAC1, TRILUMEN FILTERED TUBE SET WAS ALSO USED IN THIS PROCEDURE AND WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING

  Patient problems: Air Embolism

  MAUDE report 18150514 ↗
• MalfunctionSep 28, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT WAS BEING USED DURING A ROBOTIC PROSTATECTOMY PROCEDURE ON (B)(6) 2023. DATE WHEN IT WAS REPORTED ¿DURING A ROBOTIC PROSTATECTOMY, SURGEONS AND STAFF WERE ALSO HARVESTING MULTIPLE LYMPH NODES, PLACING THEM INTO ROBO-8 ANCHOR SPECIMEN BAG. SPECIMEN BAG BECAME STUCK INSIDE THE 12MM AIRSEAL ACCESS PORT. THE SCRUB ASSISTANT USED A FAIR AMOUNT OF FORCE TO TRY AND REMOVED THE SPECIMEN AND BAG. THE 12 MM AIRSEAL PORT CRACKED, A SMALL BLUE PLASTIC PIECE AND INNER CLEAR CANNULA BECAME DISLODGED FROM THE AIRSEAL PORT. BLUE PLASTIC PIECE WAS RETRIEVED, AN X-RAY WAS DONE TO CONFIRM THERE WERE NO OTHER PIECES INSIDE.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832455 ↗
• MalfunctionApr 24, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER IAS12-120LPI, AIRSEAL 12/120MM LPI PORT WAS BEING USED DURING A ROBOTIC RADICAL PROSTATECTOMY W/ PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿PA WAS INSERTING A CLIP APPLIER THROUGH A 12 AIRSEAL PORT WITH THE SOUND CAP ON. THE CLIP APPLIER CHIPPED SOME OF THE SOUND CAP PORTION OFF AND BROKE INSIDE THE CAVITY. THE DOCTOR AND TEAM WERE ABLE TO RETRIEVE. IT WAS ALSO REPORTED THE DEVICE WAS RETRIEVED USING "GRASPER USED BY DOCTOR ON THE ROBOT TO PICK UP THE BLUE PIECE.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND REPORTED ¿A FEW MINUTES DELAY.¿ THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿FINE.¿ THERE WAS NO REPORT OF INJURY MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794152 ↗
• InjuryApr 18, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT, WAS BEING USED DURING A ROBOTIC ASSISTED EXCISION MEDIASTINAL MASS PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿A PIECE OF THE BLUE SEAL BROKE OFF IN THE PATIENT AND WAS NOT FOUND.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE SURGEON USED A SCOPE TO SEARCH FOR THE FRAGMENTATION. THE PROCEDURE WAS COMPLETED WITH A 10-15-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE FRAGMENT LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16760399 ↗
• MalfunctionFeb 21, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT WAS USED DURING A THORACIC LOBECTOMY ON THE DATE OF (B)(6) 2023 WHEN IT WAS REPORTED, ¿I WANTED TO REPORT THIS PRODUCT COMPLAINT FROM ONE OF MY ACCOUNTS (B)(6) HOSPITAL. IT IS IN REGARDS TO THE SOUND CAP MATERIAL THAT WAS FOUND IN PATIENT THAT LOOKS LIKE IT WAS TORN OFF OR CAME OFF SOUND CAP. I ATTACHED A PICTURE HERE AS WELL. FOR MONTHS WE HAVE HAD A SURGEON COMPLAINING ABOUT SEEING A BLUE FLECK IN HER PATIENTS ON HER ROBOTIC CASES. WE HAD INTUITIVE IN TO OBSERVE AND TRY TO FIGURE OUT WHAT THAT SUBSTANCE WAS AND TO OBTAIN THE PIECE TO CHECK WHAT IT WAS. NOTHING DEFINITIVE WAS DECIDED BY THEIR OBSERVATIONS. TODAY ANOTHER SURGEON HAD A BLUE PIECE WHICH WAS OBTAINED FROM THE PATIENT. IT WAS THE EXACT MATCH TO A HOLE IN THE 12 AIRSEAL SEAL USED ON THE CASE. YOU CAN QUITE CLEARLY SEE WHERE THAT PIECE HAS BROKEN OFF THE SEAL.¿. AFTER A SERIES OF ASSESSMENT QUESTIONS, IT WAS REPORTED THE FRAGMENTATION WAS RETRIEVED WITH GRASPERS. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED AS NORMAL. THERE WAS NO PATIENT INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION FOR THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409394 ↗
• MalfunctionJan 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS12-120LPI, AIRSEAL 12/120MM LPI PORT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 12DEC22 WHEN IT WAS REPORTED ¿SEAL FROM SOUND CAP BROKE OFF AND FELL INSIDE PATIENT WHEN GRASPER WAS USED¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENTS WERE RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185500 ↗
• MalfunctionJan 9, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT, WAS BEING USED DURING A UROLOGY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿FLAP OF SOUND CAP FELL OFF INTO THE PATIENT AND WAS RETRIEVED¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120162 ↗
• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS12-120LPI, WAS BEING USED ON (B)(6) 2021 DURING A ROBOTIC ASSISTED LAPAROSCOPIC GASTRIC BYPASS PROCEDURE AND ¿THE RUBBER GASKET/PIECE OF THE 12MM AIRSEAL ACCESS PORT SOUND CAP SPLIT AND FELL INTO THE PATIENT AS THEY WERE INSERTING THE STAPLER. THEY WERE ABLE TO REMOVE THE PIECES LAPAROSCOPICALLY WITH NO HARM TO THE PATIENT." THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT, IT WAS FOUND THAT THE EVENT HAPPENED WHEN THE SURGICAL RESIDENT INSERTED A COVIDIEN LAPAROSCOPIC STAPLER THROUGH THE PORT. THE RESIDENT FELT THAT THE TIP OF THE STAPLER LOAD CAUGHT THE RUBBER AND ESSENTIALLY SPLIT IT INTO TWO PIECES. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384804 ↗
• MalfunctionFeb 17, 2021Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER (B)(4) ON 3FEB21. A MEDWATCH, (B)(4) , WAS ALSO RECEIVED FROM THE FDA AFTER REQUESTING ADDITIONAL INFO ON THE MAUDE RECORD FINDINGS. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE IAS12-120LPI, AIRSEAL 12/120MM LPI PORT. THE DATE OF THE PROCEDURE WAS (B)(6) 2020. REPORT STATES "AT THE END OF THE PROCEDURE, DOCTOR WAS REMOVING THE AIRSEAL TROCAR FROM THE ABDOMEN. A SMALL PART OF THE TIP BROKE OFF. DOCTOR RETRIEVED THE PART THAT BROKE OFF AND REMOVED THE TROCAR." THE REPORT GIVES FURTHER DETAILS ON THE DIAGNOSIS OF THE PATIENT, PRE-OP DIAGNOSIS: GRADE 2 ENDOMETRIAL CANCER, MULTIPLE PRIOR ABDOMINAL SURGERIES. POST OP DIAGNOSIS: GRADE 2 ENDOMETRIAL CANCER, MULTIPLE PRIOR ABDOMINAL SURGERIES. AT THE TIME OF USE THE PATIENT WAS UNDERGOING A ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, SENTINEL NODE MAPPING AND EXCISION, LYSIS OF ADHESIONS X 30 MINUTES PROCEDURE. WHEN IT WAS NOTED THAT THE SUPRAPUBIC 12 MM AIRSEAL PORT WAS DAMAGED WITH A SMALL JAGGED EDGE AT THE INTRAPERITONEAL TIP OF THE TROCAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337110 ↗
• MalfunctionDec 15, 2020Break

  AT THE END OF THE PROCEDURE, DOCTOR WAS REMOVING THE AIRSEAL TROCAR FROM THE ABDOMEN. A SMALL PART OF THE TIP BROKE OFF. DOCTOR RETRIEVED THE PART THAT BROKE OFF AND REMOVED THE TROCAR. PRE-OP DIAGNOSIS: GRADE 2 ENDOMETRIAL CANCER, MULTIPLE PRIOR ABDOMINAL SURGERIES. POST OP DIAGNOSIS: GRADE 2 ENDOMETRIAL CANCER, MULTIPLE PRIOR ABDOMINAL SURGERIES. PROCEDURE PERFORMED: ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, SENTINEL NODE MAPPING AND EXCISION, LYSIS OF ADHESIONS X 30 MINUTES PROCEDURE: IT WAS NOTED THAT THE SUPRAPUBIC 12 MM AIRSEAL PORT WAS DAMAGED WITH A SMALL JAGGED EDGE AT THE INTRAPERITONEAL TIP OF THE TROCAR. THIS HAD NOT BEEN IN CONTACT WITH THE INTRAPERITONEAL CONTENTS DURING THE SURGERY. THE ABDOMEN WAS RE-INSUFFLATED, AND THE COLON AND LOOPS OF TERMINAL ILEUM IN THE PELVIS WERE EXAMINED AND NO INJURIES WERE APPRECIATED. THE REMAINING PORTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010549 ↗