Anchor Tissue Retrieval System TRS-ROBO-8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20653405988523), received between Sep 18, 2024 and Oct 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS-ROBO-8L, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED IN A ROBOTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2025, AND ¿SPECIMEN BAG RIPPED HORIZONTALLY 1 INCH FROM THE BASE OF THE BAG WHILE THE SPECIMEN BAG WAS BEING REMOVED FROM THE PATIENT THROUGH THE INCISION. SPECIMEN GOT STUCK IN BETWEEN PATIENT'S SKIN AND FASCIA. BAG WAS NOT PUNCTURED DURING PROCEDURE.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A DELAY OF 15 MINUTES. FURTHER ASSESSMENT FOUND THE SPECIMEN WAS RETRIEVED WITH A CARMALT INSTRUMENT AND THE SURGICAL FIELD WAS NOT CONTAMINATED. THE BAG DID NOT FRAGMENT, BUT "RIPPED IN ONE PLACE. AND THE SPECIMEN GOT STUCK BEHIND IT" AND "SURGICAL RETRIEVAL OF THE SPECIMEN WAS NEEDED.THE SPECIMEN WAS LARGER THAN THE INCISION CREATED TO REMOVE IT. SO, THE BAG RIPPED WHILE TRYING TO PULL IT OUT THROUGH AN INCISION THAT WAS MUCH SMALLER THAN THE SPECIMEN INSIDE OF THE BAG. THEY HAD TO MAKE A LARGER INCISION TO GET THE ACTUAL SPECIMEN OUT.". THE PATIENT'S STATUS IS "DOING WELL.". 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 23379349 ↗
• MalfunctionSep 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS-ROBO-8L, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED DURING A ROBOTIC CHOLE PROCEDURE ON (B)(6)2024, AND ¿WHILE THE PA WAS REMOVING THE BAG WITH SPECIMEN INSIDE THE BOTTOM OF THE BAG RIPPED ALONG THE BOTTOM SEAM LEAVING THE SPECIMEN IN THE PATIENT BETWEEN THE SKIN AND FASCIA. THE PA WAS ABLE TO REMOVE THE SPECIMEN WITH LITTLE TROUBLE AND INTACT.¿. FOLLOW-UP ASSESSMENT FOUND THERE HAD BEEN NO FRAGMENTATION OF THE BAG. "THE BAG RIPPED ALONG THE LOWER SEAM, ALONG THE CURVE OF THE BAG"; "THE BAG WAS IN ONE PIECE AND ALL PIECES WERE COLLECTED FOR THE REP.¿; "THE GALLBLADDER THAT WAS BEING REMOVED WAS INTACT WHEN REMOVED"; AND "THE GALLSTONE WAS 3CMX2.5CM IN DIAMETER". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. "IT TOOK THE PA ABOUT 10-15 MINS TO REMOVED THE WHOLE GALLBLADDER FROM THE PATIENT. IT WAS THE END OF THE CASE; REMOVAL OF THE SPECIMEN WAS ALL THAT WAS LEFT.". 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 REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245370 ↗