SUPERBAG NI0140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10850013527608), received between Aug 4, 2023 and Jul 1, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  7MM CATCH BAG BROKE AND RIPPED OPEN DURING SURGERY. DEVICE WAS INSIDE PATIENT AT TIME OF MALFUNCTION. THE SURGERY WAS A DAVINCI LAPAROSCOPIC CHOLECYSTECTOMY WITH FIREFLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371382 ↗
• MalfunctionAug 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  SURGEON INSERTED BAG INTO PATIENT ABDOMINAL CAVITY, ONCE BAG WAS DEPLOYED, BAG TORE AT BASE. PROCEDURE WAS A LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949930 ↗
• MalfunctionAug 4, 2023Detachment of Device or Device Component; Material Protrusion/Extrusion; Detachment of Device or Device Component; Material Protrusion/Extrusion

  PER PMI REP, ACCOUNT HAS BEEN USING PMI SPECIMEN BAGS FOR APPROXIMATELY 60 DAYS, SO THEY ARE RELATIVELY NEW TO THE PMI BAGS, BUT NOT TO SPECIMEN RETRIEVAL BAGS IN GENERAL. SPOKE WITH DR. KUHNEN, TOLD US THAT SHE RECEIVED THE BAG ALREADY PULLED BACK INTO THE INTRODUCER BY A VERY QUALIFIED NURSE. SHE DID NOT GIVE THE NURSE'S NAME. THE DR. SAID SHE NEVER STOPPED BY DURING THE SEVERAL DAYS OF IN-SERVICING BUT DID WATCH THE EXPLAINER VIDEO. SHE SAID SHE WAS USING A 12 TROCAR FOR THE 7MM BAG. UPON DEPLOYING THE BAG, SHE NOTICED THAT BOTH PRONGS WERE EXPOSED. SHE SAID NO OTHER DEVICES WERE INTRODUCED OTHER THAN A GRASPER TO PUT THE SPECIMEN INTO THE BAG. WHEN REMOVING THE BAG, IT RIPPED MORE. THERE WAS NO PATIENT INJURY DURING THIS INCIDENT. PICTURE ATTACHED. THE PROVIDED PICTURE ONLY SHOWS ONE ARM EXPOSED SLIGHTLY AT THE VERY END OF THE BAG, BUT THE REPORT INDICATES BOTH ARMS WERE EXPOSED. CAN YOU CLARIFY? NO RESPONSE FROM THE USER. WAS THERE ANY INCREASE FORCE OR EFFORT REQUIRED DURING DEPLOYMENT? NO UNUSUAL FORCE OR EFFORT USED OR REQUIRED. HOW MANY TIMES WAS THE BAG USED? BAG USED ONLY ONCE. CAN YOU ESTIMATE THE TIME BETWEEN WHEN THE BAG WAS LOADED INTO THE INTRODUCER, TO WHEN IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458702 ↗