AIRSEAL IAS12-100LPIRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10845854045640), received between Aug 30, 2021 and Jul 15, 2026 — classified as 11 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (60 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-2474-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25824776 ↗
• MalfunctionJul 10, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25777499 ↗
• MalfunctionJun 17, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A ROBOT-ASSISTED GASTRIC PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿THE BLUE PORTION OF THE SOUND REDUCTION CAP CAUGHT ON FORCEPS AND WAS DAMAGED, AND A FRAGMENT FELL INTO THE ABDOMINAL CAVITY; HOWEVER, IT WAS SUCCESSFULLY RETRIEVED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED 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 25534267 ↗
• MalfunctionMay 6, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2026, AND ¿THE VALVE OF THE AIRSEAL TROCAR SOUND CAP WAS DAMAGED, SO ITS USE WAS DISCONTINUED AND THE ENTIRE TROCAR WAS REPLACED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT FOUND "THE INFORMATION IS VERY LIMITED, BUT THE FRAGMENT DID NOT FALL INTO THE SURGICAL SITE". 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 25093094 ↗
• InjuryFeb 12, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON (B)(6) 2026 DURING A ROBOT-ASSISTED HIGH ANTERIOR RESECTION AND ¿THE DISTAL TIP WAS DAMAGED, AND A FRAGMENT BECAME DETACHED AND FELL INTO THE BODY. NOT ALL FRAGMENTS COULD BE RETRIEVED, RESULTING IN A RETAINED FRAGMENT WITHIN THE BODY.¿ UPDATE; JAN 30, 2026 ¿WE HAVE OBTAINED ADDITIONAL INFORMATION. IT WAS REPORTED THAT "AN AIR SEAL WAS USED DURING A ROBOTIC-ASSISTED HIGH ANTERIOR RESECTION IN THE SURGICAL DEPARTMENT. WHEN THE AIR SEAL TROCAR WAS REMOVED AT THE END OF THE SURGERY, THE TIP WAS FOUND TO HAVE BROKEN. SOME OF THE FRAGMENTS WERE RETRIEVED, BUT NOT ALL OF THEM REMAINED INSIDE THE PATIENT'S BODY. THE ABDOMEN WAS CLOSED AS IS. WE REQUEST THAT YOU INVESTIGATE THE POSSIBLE CAUSES OF THE BREAKAGE AND WHETHER THERE WAS A DEFECT IN THE PRODUCT AND REPORT THE RESULTS TO US. FURTHERMORE, AS THIS INCIDENT IS BEING HANDLED BY OUR IN-HOUSE RISK MANAGER, WE WOULD APPRECIATE A PROMPT RESPONSE.¿ THERE WAS NO REPORT OF IMPACT, PROLONGED HOSPITALIZATION OR MEDICAL INTERVENTION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNA

  Patient problems: Foreign Body In Patient

  MAUDE report 24324501 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE, WAS BEING USED DURING A ROBOT-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿WHILE RETRIEVING TISSUE FROM A TROCAR USING ANCHOR II, THE INNER TUBE FELL OFF AND INTO THE BODY. THE OPERATION WAS CARRIED OUT AS NORMAL. THE FALLEN PART WAS RETRIEVED USING FORCEPS.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED 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 23541421 ↗
• InjuryNov 12, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON (B)(6) 2025 DURING AN RARP PROCEDURE AND ¿THE INSIDE OF THE TROCAR WAS DAMAGED WHEN USED IN CONJUNCTION WITH ANCHOR II. THE FRAGMENTS WERE RECOVERED, BUT IT IS UNCLEAR WHETHER ALL OF THEM WERE RECOVERED." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE UNKNOWN DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF THE POSSIBILITY OF FRAGMENTS OF THE DEVICE REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23532392 ↗
• MalfunctionOct 8, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A IVOR LEWIS ESOPHAGECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING SURGICAL PROCEDURE, IN THE SECOND PART OF THE OPERATION, WHILE THE ESOPHAGUS WAS BEING MOBILIZED THORACOSCOPICALLY, A PART OF THE TROCAR PORT WAS BROKEN. LUCKILY, THE OPERATION WAS COMPLETED WITHOUT ANY MAJOR COMPLICATIONS, THE BROKEN PART WAS REMOVED FROM THE PATIENT THORACIC CAVITY.¿. THE FRAGMENTATION WAS RETRIEVED FROM THE PATIENT AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF ANY DELAYS. 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 23243004 ↗
• MalfunctionOct 7, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A LAPAROSCOPIC SURGERY PROCEDURE ON 11SEP25 WHEN IT WAS REPORTED, ¿DURING SURGERY, SOME KIND OF DEBRIS WAS FOUND IN THE ABDOMINAL CAVITY, AND WHEN IT WAS RETRIEVED, IT TURNED OUT TO BE A BROKEN PIECE OF THE TIP OF THE AIR SEAL TROCAR. THE DEBRIS WAS RETRIEVED, SO IT DID NOT REMAIN INSIDE THE BODY.". THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED WITH AN UNKNOWN ALTERNATE DEVICE. THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR 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 23232351 ↗
• InjurySep 30, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE, WAS BEING USED DURING A THORACOSCOPIC ESOPHAGEAL RECONSTRUCTION PROCEDURE ON (B)(6)2025 WHEN IT WAS REPORTED, ¿WHEN THE TROCARS WERE REMOVED FROM THE BODY, DAMAGE TO THE TIPS OF THE 12MM AIR SEAL TROCARS WAS NOTICED. ONE TIP WAS BROKEN AND CHIPPED, AND THE OTHER HAD A CRACK IN THE TIP. THE THORACIC CAVITY WAS CHECKED FOR BROKEN PIECES, BUT THEY WERE NOT FOUND.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23181104 ↗
• MalfunctionAug 20, 2025Material Fragmentation; Material Fragmentation

  CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/ BLADELESS OPTICAL TIP WAS BEING USED ON AN UNKNOWN DATE AND ¿DURING THE ROBOTIC SURGICAL PROCEDURE, WE CONFIRMED THAT THE TROCAR HAD BEEN BROKEN BEFORE CLOSING THE WOUND. WE CHECKED THE ABDOMINAL CAVITY FOR ABOUT AN HOUR AND REMOVED ANY INTERNAL REMAINS. TIMING OF DAMAGE DISCOVERY: THE DAMAGE WAS CONFIRMED WHEN THE TIP OF THE TROCAR WAS VIEWED FROM INSIDE THE LAPAROSCOPE BEFORE CLOSURE. THE DAMAGED ITEM WAS CONFIRMED BY INTRAPERITONEAL OBSERVATION FOR OVER AN HOUR, AND WAS DISCOVERED AND RETRIEVED FROM THE SMALL INTESTINAL MESENTERY. PRODUCTS PLACED IN THE AIR-SEAL TROCAR: GAUZE, SUCTION TUBE, LAPAROSCOPIC FORCEPS.¿ THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS A DELAY OF 1 HOUR. THERE WAS NO IMPACT OR INJURY TO 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 22848362 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿THE BLUE RUBBER PART OF THE SILENCER TORE OFF AND FELL INTO THE PATIENT'S BODY. THE DETACHED RUBBER PIECE HAS ALREADY BEEN RETRIEVED FROM THE BODY.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN ALTERNATE DEVICE. 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 22628784 ↗
• MalfunctionMay 2, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A ROBOTIC DIAPHRAGMATIC LIGATION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿12MM X 100MM AIRSEAL ACCESS PORT, SOUND CAP HAD ONE OF THE BLUE LEAFLETS TEAR OFF IN THE CASE.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND THAT ¿THE TROCAR WAS IN USE ON THE STERILE FIELD, ONE OF THE BLUE LEAFLETS FELL OFF DURING INSTRUMENT INSERTION WITH A MARYLAND. THE BLUE LEAFLET FELL INTO THE PATIENT- THEY WERE ABLE TO EXTRACT THE LEAFLET AS SOON AS IT HAPPENED. THE PATIENT IS OKAY. THE NURSE TOLD ME THAT DURING THE PROCEDURE THERE WERE A LOT OF INSTRUMENT EXCHANGES THROUGH THE AIRSEAL ACCESS PORT.¿. THERE WAS ¿NOT MUCH OF A DELAY¿ DUE TO THE INCIDENT. 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 21949504 ↗
• MalfunctionMar 18, 2025Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6)2025, AND ¿BLUE SEAL ON AIRSEAL DEVICE BROKE INTO 4 PIECES WHEN RESIDENT DOCTOR WAS INSERTING A ENDO ¿CIGAR¿ GAUZE THROUGH THE PORT¿. THE EVENT WAS DESCRIBED AS A PRODUCT PROBLEM, NOT AN ADVERSE EVENT. FURTHER ASSESSMENT CONFIRMED THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE. 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 21631593 ↗
• MalfunctionMar 5, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON (B)(6) 2025 DURING A ROBOT-ASSISTED ENDOSCOPIC ESOPHAGECTOMY AND THE ¿AIRSEAL WAS USED DURING DAVINCI SURGERY (ESOPHAGUS). AFTER ROLLOUT, WHEN THE AIRSEAL PORT WAS REMOVED, THE TIP OF THE AIRSEAL PORT BROKE. THE FALLEN PIECES WERE IMMEDIATELY RETRIEVED WITH GRASPING FORCEPS. THE RETRIEVAL PROCESS DID NOT TAKE LONG. ALTHOUGH NO SPECIAL OPERATIONS WERE PERFORMED DIFFERENTLY THAN USUAL, DR. ¿ SAID, ¿MAYBE I USED A LITTLE TOO MUCH FORCE,¿ AND IT WAS NOT A SERIOUS PROBLEM.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. 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 21527803 ↗
• InjuryJan 8, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN A THORACOSCOPIC ESOPHAGECTOMY PROCEDURE ON (B)(6) 2024, AND ¿THE TROCAR BROKE DURING INTRATHORACIC MANIPULATION AND FELL INTO THE PATIENT'S BODY. SURGEONS USED GRASPING FORCEPS TO RETRIEVE THE FRAGMENTS, BUT IT CANNOT BE SAID THAT THEY WERE COMPLETELY RECOVERED. THE SURGEON SAID THAT THE ADHESIONS WERE SEVERE AND THE TROCAR WAS SWUNG FROM SIDE TO SIDE WITH CONSIDERABLE FORCE, CAUSING DAMAGE TO THE OUTER TUBE, AND THAT THE NARROW INTERCOSTAL SPACES MAY HAVE BEEN CONTRIBUTING FACTORS.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT WAS ATTEMPTED, AND "THERE IS NO EXTRA INFORMATION AT THIS TIME.". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF THE POSSIBILITY OF RETAINED FOREIGN BODY, SINCE IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21101931 ↗
• MalfunctionDec 3, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON (B)(6) 2024 AND "IT WAS REPORTED THAT A BROKEN PLASTIC TROCAR HAD FALLEN INTO THE ABDOMINAL CAVITY AND WAS RETRIEVED WITH FORCEPS. USED ROBOTIC SURGERY WAS HINOTORI." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. 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 20830987 ↗
• MalfunctionNov 11, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS BEING USED IN A LOWER ANTERIOR RESECTION PROCEDURE ON (B)(6) 2024, AND ¿ THE TIP OF TROCAR WAS BROKEN AND THE FRAGMENT WAS RETRIVED.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND THERE WAS NO IMPACT TO THE PATIENT OR USER. FURTHER ASSESSMENT FOUND THAT "WHEN THE ASSISTANT DOCTOR PUT HIS HAND INTO THE SURGICAL FIELD TOWARDS THE END OF THE SURGERY, HE FOUND A FOREIGN OBJECT ON HIS FINGER, AND WHEN HE PICKED IT UP, HE CHECKED IT WITH A RESIN MATERIAL AND FOUND THAT THE TIP OF THE AIR SEAL TROCAR WAS DAMAGED. AS AN AS TROCAR WAS USED AS AN ASSIST PORT, INSERT FORCEPS AND DEVICES.". 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 20654121 ↗
• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON AN UNKNOWN DATE DURING A ROBOT ASSISTED PROSTATECTOMY PROCEDURE WHEN IT WAS REPORTED ¿TOWARDS THE END OF THE OPERATION, THE SURGEON DISCOVERS THAT THERE ARE SMALL PIECES OF PLASTIC LYING FREELY IN THE ABDOMEN. THE PIECES ARE PICKED UP WITH A LAPAROSCOPIC FORCEPS AND WHEN ALL PORTS ARE REMOVED, THEY SEE THAT PIECES ARE MISSING FROM THE AIRSEAL PORT. THEY PATCH THE PIECES TOGETHER TO SEE THAT NOTHING IS MISSING AND COMES TO THE CONCLUSION THAT ALL THE PIECES ARE THERE AND NOTHING IS LEFT IN THE PATIENT.". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR 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 20565576 ↗
• InjuryOct 7, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS12-100LPI, 12 MM ACCESS PORT, WAS BEING USED ON (B)(6) 2024 DURING A ROBOTIC ASSISTED LOBECTOMY PROCEDURE AND ¿PART OF THE BLUE VALVE IN THE TOP VALVE FELL INTO THE SURGICAL SITE. THIS WAS OBSERVED AND REMOVED. MAY HAVE ENDED UP WITH A FRAGMENT NOT OBSERVED. AS I UNDERSTAND THIS FRAGMENT WAS RIPPED OFF DURING INSERTION OF INSTRUMENT, MOST PROBABLY ENDO GIA". THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ¿ANOTHER CONNECTION¿ AND A 5 MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE DEVICE FRAGMENTATION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20384484 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS BEING USED DURING A ROBOT-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2024, AND ¿THE AIR SEAL TROCAR BROKE, AND BOTH THE INNER AND OUTER LAYERS OF THE DOUBLE STRUCTURE FELL INTO THE BODY. THE SURGEON SAID THAT IT SHOUD NOT HAVE BROKEN UNLESS SOME KIND OF EXESSIVE FORCE HAD BEEN APPLIED, BUT HE HAD NO IDEA WHEN IT HAPPENED. HE ALSO REPORTED THAT HE HAD BEEN HAVING DIFFICULTY REMOVING THE ANCHOR II BAG THAT HAD BEEN USED TO RETRIEVE TISSUE FRAGMENTS AND WAS UNSURE WHETHER THIS INCIDENT OCCURRED DURING THIS PROCEDURE OR ANOTHER PROCEDURE. THE ASSISTANT DOCTOR ALSO SAID HE DIDN'T KNOW BECAUSE IT WAS UNCLEAR WHETHER THE DEVICE HAD COME INTO CONTACT WITH THE DA VINCI ARM.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. FOLLOW-UP ASSESSMENT CONFIRMED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A DELAY OF "ABOUT 20 MIN", AND THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357968 ↗
• MalfunctionSep 12, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP WAS BEING USED ON (B)(6) 2024 DURING A ROBOT-ASSISTED GASTRECTOMY AND ¿THE SOUND REDUCTION CAP VALVE WAS BROKEN AND FELL INTO THE PATIENT'S BODY. THE FRAGMENT WAS VISIBLE INSIDE THE PATIENT'S BODY CABITY AND WAS RETRIEVED USING FORCEPS.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. 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 20199302 ↗
• MalfunctionAug 28, 2024Material Fragmentation; Material Fragmentation

  UPDATE: A REVIEW OF THE DEVICE FOUND THAT ALL PIECES OF THE DEVICE WERE RETURNED; THEREFORE THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT FROM FRAGMENTATION OF THE DEVICE. THE INCIDENT TYPE HAS BEEN CHANGED FROM SERIOUS INJURY TO MALFUNCTION BECAUSE OF NEW FINDINGS. CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS BEING USED DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE ON (B)(6) 2024, AND ¿THE TROCAR WAS CRACKED AND THE FRAGMENTS FELL INTO THE PATIENT'S BODY. IT IS SUSPECTED THAT SURGEONS ATTEMPTED TO RETRIEVE ALL THE FRAGMENTS BUT WERE UNABLE TO DO SO¿. FURTHER INFORMATION WAS PROVIDED, INDICATING THAT IT WAS A NON-ROBOTIC PROCEDURE AND ¿IT WAS CONFIRMED WHEN OBSERVING THE INSIDE OF THE CHEST CAVITY AT THE END OF THE CHEST OPERATION. FORCEPS WERE INSERTED THROUGH A SMALL INCISION AND RETRIEVED THE FRAGMENTS. IT WAS UNCLEAR WHETHER EVEN THE SMALLEST FRAGMENTS COULD BE RECOVERED, SO THEY CARRIED OUT OBSERVATION AND SUCTION WORK. THERE IS NO REPORT OF EXTENSION OF HOSPITAL STAY OR ADDITIONAL TREATMENT. THE PATIENT IS INFORMED BY THE DOCTOR OF THE POSSIBILITY OF DAMAGE AND INTERNAL DEPENDENCE.¿ T

  Patient problems: Foreign Body In Patient

  MAUDE report 20088919 ↗
• MalfunctionJul 1, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IAS12-100LPI, AIRSEAL 12/100MM LPI PORT WAS BEING USED ON (B)(6) 2024 DURING A THORACOSCOPIC ESOPHAGEAL MALIGNANT TUMOR SURGERY AND THE ¿TIP OF TROCAR WAS DAMAGED WHEN THE TROCAR WAS BEING REMOVED AFTER CHEST MANIPULATION. THE PATIENT SEARCHED FOR THE BROKEN PIECE IN THE CHEST CAVITY, BUT COULD NOT FIND IT, SO ABDOMINAL SURGERY WAS PERFORMED. AFTER THE ANASTOMOSIS, THE PATIENT WAS PLACED BACK IN THE PRONE POSITION, AND THE FRAGMENTS WERE SEARCHED AND RETRIEVED FROM THE CHEST WALL.¿. PER FURTHER ASSESSMENT IT WAS DISCOVERED THAT THE ABDOMINAL SURGERY WAS PART OF THE ORIGINAL SURGICAL PLAN. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. AN ALTERNATE UNKNOWN DEVICE WAS USED AND THERE WAS A 2 HOUR DELAY. 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 19646062 ↗
• InjuryMay 21, 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 AND THE ¿DISTAL TIP OF AIRSEAL 12MM PORT BROKE¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE REPORTER IS NOT SURE HOW AND WHERE THE PIECE BROKE OFF THE TROCAR AND "IT WAS NOT FOUND OR RETRIEVED". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION, ALTHOUGH NOT FOUND IN THE PATIENT, THEY CANNOT PRODUCE THE PIECE AND ITS LOCATION IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19359991 ↗