ANCHOR TISSUE RETRIEVAL SYSTEM TRS-ROBO-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20653405986147), received between Sep 18, 2023 and Aug 3, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Integrity Problem

  The bag fell apart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112722 ↗
• InjuryJul 10, 2026Material Twisted/Bent

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 26, AND ¿DURING PROCEDURE METAL PORTION OF TRS-ROBO-8 BENT AND PUNCTURED PATIENT ABDOMEN. DOCTORS USED 1 TRS-ROBO-8 AND MALFUNCTIONED, OPENED ANOTHER AND MALFUNCTIONED AGAIN.¿. ADDITIONAL INFORMATION WAS REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PUNCTURE TO THE PATIENT¿S ABDOMEN.

  Patient problems: Perforation

  MAUDE report 25780405 ↗
• MalfunctionMar 31, 2026Mechanical Problem; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS-ROBO-8 ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2026 WHEN IT WAS REPORTED ¿THE POUCH FELL OFF THE RETRIEVAL SYSTEM ON THE FIRST ATTEMPT TO RETRACT THE BAG. THE PRODUCT WAS AT THE BACK TABLE BUT NEVER MADE IT TO THE PT¿S STERILE FIELD.¿ 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 24741613 ↗
• MalfunctionJan 8, 2026Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, "TRYING TO TAKE THE GALLBLADDER OUT, AND THE STRING BROKE WHEN THEY WOULD PULL BACK CLOSED." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FROM THE REPORTER FOUND THE BAG DID NOT RIP AND THERE WAS NOTHING THAT FELL BACK INTO THE PATIENT. THERE WAS NO DEVICE FRAGMENTATION. THE SURGEON HAS TO SCRUB BACK IN TO REMOVE THE BAG. THE INCIDENT CAUSED A 5-MINUTE 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 24001899 ↗
• MalfunctionJan 6, 2026Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS-ROBO-8 ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED DURING A ROBOTIC CHOLE PROCEDURE ON (B)(6) 2025. WHEN IT WAS REPORTED ¿ANCHOR SPECIMEN ROBO-8 BAG WAS BEING USED TO REMOVE A GALLBLADDER, AND THE BAG GOT STUCK IN THE ABDOMINAL WALL. SA PULLED STRING, AND STRING BROKE DOWN BY BAG. SURGEON SCRUBBED IN AND GOT THE BAG OUT¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE SPECIMEN DID NOT FALL BACK INTO THE PATIENT OR RUPTURE AND THE BAG DID NOT FRAGMENT INTO THE SURGICAL SITE. THE BAG WAS REMOVED BY THE SURGEON WITH THE USE OF A KELLY CLAMP AND THE INCISION WAS NOT WIDENED. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY 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 23973261 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED IN A ROBOT APPENDECTOMY PROCEDURE ON APPROXIMATELY (B)(6) 2025, AND ¿UNIT CAME APART INSIDE OF PATIENT, NO PATIENT HARM RECORDED POSSIBLE USER ERROR¿. FURTHER ASSESSMENT FOUND THE BAG DID NOT RIP. "THE METAL JAWS CAME OFF THE DEVICE", COMPLETELY DETACHED AND FELL INTO THE SURGICAL SITE. ALL FRAGMENTS WERE RETRIEVED USING ROBOT GRASPERS. THE PROCEDURE WAS COMPLETED AS NORMAL WITHOUT THE USE OF AN ALTERNATE DEVICE AND A DELAY OF 5 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THE PATIENT IS REPORTEDLY "FINE". 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 22871908 ↗
• MalfunctionAug 20, 2025Material Rupture; Material Rupture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿BAG BROKE AT THE SEAM. FOR THIS PARTICULAR PROCEDURE THE BAG BROKE DURING THE GALLBLADDER EXTRACTION. THE SURGEON PULLED ON THE BAG AFTER FULL DEPLOYMENT AND THE BAG BROKE. GALLSTONE GOT STUCK IN FASCIA. THEY HAD TO GET ANOTHER ANCHOR BAG TO RETRIEVE IT.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE GALLBLADDER THEY WERE REMOVING WAS HALFWAY THROUGH THE PATIENT AND GOT STUCK ON THE GALLSTONE ONCE THE BAG BROKE. SURGEON HAD TO PUSH GALLBLADDER BACK IN AND INSERT A NEW ANCHOR BAG TO RETRIEVE IT. THERE WAS NO RUPTURE OR CONTAMINATION.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND A 15-MINUTE DELAY. THERE WAS NO REPORT PF INJURY, MEDICAL OR SURGICAL 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 22850103 ↗
• InjuryJul 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5172233) RECEIVED ON 17JUL2025. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM. THE INCIDENT OCCURRED ON 23JUN25. THE REPORT STATES THAT ¿RETRIEVAL BAG RIPPED OPEN ON THE BOTTOM SEAM WHILE BEING DEPLOYED TO REMOVE GALLBLADDER. A SMALL CUTDOWN AND EXTRA TIME WAS NEEDED TO RETRIEVE THE GALLBLADDER.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "PORT SITE INCISION WAS SLIGHTLY EXTENDED TO REMOVE GALLBLADDER." THE RETRIEVAL BAG DID NOT FRAGMENT.¿ THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "I AM UNAWARE OF ANY ISSUES" AND THERE WAS NO EXTENDED HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF INCISION SITE SLIGHTLY EXTENDED.

  Patient problems: Skin Disorders

  MAUDE report 22664651 ↗
• MalfunctionJul 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE, WAS BEING USED DURING AN XI ROBOTIC ASSISITED LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿AN ANCHOR TISSUE RETRIEVAL BAG (TRS-ROBO-8) BROKE INSIDE THE PATIENT. THE GALLBLADDER WAS PLACED INTO THE BAG. WHEN THE BAG WAS ELEVATED OFF OF THE FLOOR OF THE ABDOMEN, THE BOTTOM OF THE BAG SPLIT OPEN, AND THE GALLBLADDER FELL OUT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THE BAG SPLIT OPEN BUT REMAINED ATTACHED TO THE HANDLE. IT WAS ABLE TO BE PULLED OUT OF THE PORT SITE WHOLE. THE SPECIMEN DID NOT RUPTURE AND REMAINED INTACT. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE DELAY AND WITH THE USE OF THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL OR SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿DISCHARGED FROM HOSPITAL.¿. 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 22457256 ↗
• InjuryMay 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE WAS BEING USED ON (B)(6) 2025 DURING A ROBOTIC PROSTATECTOMY AND THE ¿SPECIMEN BAG RIPPED AT SEAM WHILE REMOVING SPECIMEN. WHEN REMOVING SPECIMEN, BAG RIPPED AT THE SEAM. THE SPECIMEN WAS LOST IN THE CAVITY TAKING LONGER THAN EXPECTED TO FIND THE PROSTATE. PATIENT HAD TO BE UNDER ANESTHESIA FOR 30-45 MINUTES LONGER THAN EXPECTED." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 22042850 ↗
• InjuryMay 16, 2025Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE, WAS BEING USED DURING A LAPAROSCOPIC GALLBLADDER REMOVAL PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THIS IS NOW THE 4TH BAG THAT THE DOCTOR HAS RIPPED. IT KEEPS RIPPING AT THE BOTTOM SEAM.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID NOT FRAGMENT OR FALL INTO THE SURGICAL SITE. THE SPECIMEN DID HOWEVER, FALL BACK INTO THE PATIENT AND CAUSE CONTAMINATION. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF MEDICAL OR SURGICAL INTERVENTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF THE PATIENT¿S ABDOMEN BEING CONTAMINATED FROM THE SPECIMEN RUPTURING AND FALLING BACK INTO THE PATIENT.

  Patient problems: Rupture

  MAUDE report 22034461 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE ROBOTIC SPECIMEN RETRIEVAL BAG HAS BEEN RIPPING AT THE SEAMS.¿. FURTHER ASSESSMENT FOUND THE BAG DID RIP DURING USE. THERE WAS NO FRAGMENTATION LEFT BEHIND. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SAME PRODUCT DEVICE. THERE WAS NO REPORT OF ANY 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 21889574 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿SPECIMEN BAG HAS BEEN RIPPING WHILE TRYING TO PULL SPECIMEN OUT OF ABDOMINAL CAVITY.¿. FURTHER ASSESSMENT FOUND THE BAG DID RIP DURING USE. THERE WAS NO FRAGMENTATION LEFT BEHIND. 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 21889573 ↗
• MalfunctionApr 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿BAG RIPPED WHILE TRYING TO GET IT OUT OF THE ABDOMEN.¿. FURTHER ASSESSMENT FOUND THAT THERE WAS NO FRAGMENTATION OF THE DEVICE AND THE SPECIMEN REMAINED INSIDE BAG. THE BAG LOOKED LIKE IT WAS CUT ACROSS THE TOP, CLEAN TEAR. A GRASPER WAS USED TO REMOVE THE BAG FROM THE PATIENT. PATIENT DISCHARGED AS PLANNED. 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 21824696 ↗
• InjuryMar 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS USED IN A ROBOT/LAP CHOLE PROCEDURE ON (B)(6) 2025 AND "ANCHOR BAGS RIPPED UPON EXITING THE PATIENT WITH THE SPECIMEN. NO INJURY TO THE PATIENT.¿. FURTHER ASSESSMENT FOUND "FAILURE OF BAG, SEAM SPLIT DOWNSIDE". NO DEVICE FRAGMENTS OR PORTIONS OF SPECIMEN FELL INTO THE PATIENT. THERE WAS NO CONTAMINATION AND NO CHANGE IN THE WOUND CLASSIFICATION, BUT "INCISION EXPANDED TO RETRIEVE GALLBLADDER, HAD TO PUT IN A FASCIAL STITCH.". THE PROCEDURE WAS COMPLETED WITH A DELAY OF "MAYBE 7 MINUTES TO RETRIEVE GALLBLADDER AND THEN CLOSE INCISION". THERE WAS "NO EXTENDED STAY, NO LONG-TERM AFFECT TO PATIENT". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF EXTENDED INCISION REQUIRING FASCIAL STITCH.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708315 ↗
• MalfunctionMar 24, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED DURING A GALLBLADDER PROCEDURE ON AN UNKNOWN DATE AND THE ¿BAGS RIPPED¿. PER FURTHER ASSESSMENT IT WAS REPORTED THAT "THERE WERE TWO SEPARATE OCCASIONS THAT THE BAG BROKE OVER THE PAST FEW WEEKS. IT WAS TWO DIFFERENT PATIENTS. THERE WAS NO RETAINED FRAGMENTS OR COMPONENTS LEFT BEHIND. THERE WAS NO INJURY TO THE PATIENTS. THE BAGS BROKE WHILE TRYING TO REMOVE THE GALLBLADDER.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN 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 21678027 ↗
• MalfunctionMar 24, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED DURING A GALLBLADDER PROCEDURE ON (B)(6) 2025 AND THE ¿BAGS RIPPED¿. PER FURTHER ASSESSMENT IT WAS REPORTED THAT "THERE WERE TWO SEPARATE OCCASIONS THAT THE BAG BROKE OVER THE PAST FEW WEEKS. IT WAS TWO DIFFERENT PATIENTS. THERE WAS NO RETAINED FRAGMENTS OR COMPONENTS LEFT BEHIND. THERE WAS NO INJURY TO THE PATIENTS. THE BAGS BROKE WHILE TRYING TO REMOVE THE GALLBLADDER.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN 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 21678025 ↗
• InjurySep 10, 2024Material Rupture; Material Rupture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS-ROBO-8 ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A CHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿ANCHOR ROBO8 SPECIMEN BAG RUPTURED WHEN REMOVING A GALLBLADDER, SPILLING THE CONTENTS INCLUDING A GALLSTONE OUT AT THE END OF THE PROCEDURE.¿. IT WAS ALSO REPORTED THAT ¿NO PIECES OF BAG FELL INTO PATIENT AS THE BAG FAILURE WAS ON THE BOTTOM SEAM. HAD TO WIDEN INCISION, AND INCLUDE MORE SUCTION IRRIGATION, AND SCOPE THE ABDOMEN TO CONFIRM EVERYTHING WAS REMOVED." THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 5-10 MINUTE DELAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "NO APPARENT HARM DONE AND NO FURTHER ORDERS GIVEN BY THE SURGEON AS HE WAS FULLY AWARE OF THE EVENTS. SHE WAS DISCHARGED SAME DAY.". THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO INCISION NEEDING TO BE WIDENED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179334 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE BAG HAS RIPPED WHEN REMOVED FROM THE PATIENT LEAVING PARTS OF THE BAG INSIDE THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER QUESTIONING FOUND THAT ¿THE BAGS ARE BREAKING AND DROPPING INSIDE THE PATIENT WHEN THE SURGEONS ATTEMPTS TO PULL THEM OUT THROUGH THE PORT HOLE. THE ITEM WAS RETRIEVED.¿ THE PROCEDURE WAS COMPLETED WITH A 5-10-MINUTE DELAY USING ANOTHER 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 20143941 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS-ROBO-8, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 27MAY24 WHEN IT WAS REPORTED, ¿THE BAG HAS RIPPED WHEN REMOVED FROM THE PATIENT LEAVING PARTS OF THE BAG INSIDE THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER QUESTIONING FOUND THAT ¿THE BAGS ARE BREAKING AND DROPPING INSIDE THE PATIENT WHEN THE SURGEONS ATTEMPTS TO PULL THEM OUT THROUGH THE PORT HOLE. THE ITEM WAS RETRIEVED.¿ THE PROCEDURE WAS COMPLETED WITH A 5-10-MINUTE DELAY USING ANOTHER 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 20143877 ↗
• MalfunctionSep 18, 2023Burst Container or Vessel; Burst Container or Vessel

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF HIS CUSTOMER THAT THE TRS-ROBO-8, ANCR TISSUE RETRIEVAL SYSTEM, 8MM, 125ML (5/BX) WAS BEING USED DURING A SURGICAL PROCEDURE FOR A RIGHT ANTERIOR MEDIASTINAL MASS WITH THYMECTOMY ON (B)(6) 2023 AND ¿HAD TWO 8MM ANCHOR BAGS RIP WHILE EXTRACTING A MASS FROM THE PATIENT.¿ FURTHER ASSESSMENT CONFIRMED THAT "THE BAG DID NOT FRAGMENT OFF AND DIDN'T NOT HAVE ANY PIECES OR COMPONENTS FALL INTO THE PATIENT". THE PROCEDURE WAS COMPLETED WITH A REPORTED 20-MINUTE DELAY, USING ¿OUR 12MM ANCHOR BAG¿ AS AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR PROLONGED 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 17767291 ↗