SUPERBAG PNI2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10850013527646), received between Jul 6, 2023 and Nov 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Puncture/Hole; Material Puncture/Hole

  DESCRIBE THE EVENT OR PROBLEM: DURING PROCEDURE, A 15 MM ENDOCATCH BAG WAS USED FOR THE EXTRACTION OF THE PATIENT'S UTERUS VIA THE VAGINA. DURING THE PROCEDURE, THE BAG DID NOT FULLY DEPLOY WHEN INITIALLY UTILIZED. THIS WAS THEN FOLLOWED BY THE METAL RIM RELEASING IN THE PERITONEAL CAVITY; THE BARE METAL TIPS WERE IDENTIFIED BY CLINICAL STAFF TO BE JUTTING OUT AWKWARDLY BEFORE THE BAG WAS COMPLETELY CINCHED. AS THE ENDOCATCH BAG WAS BEING REMOVED VAGINALLY, THE JUTTING BARE METAL TIPS CAUSED TRAUMA ALONG THE VAGINAL CANAL CREATING A LACERATION OF THE TISSUE. STAFF NOTED THAT THE VAGINAL LACERATION WAS NOT SIGNIFICANT BUT THE PATIENT WAS TAKEN BACK TO THE PACU [POST ANESTHESIA CARE UNIT] AFTER THE BLEEDING INCREASED IN RECOVERY AND HAD TO GO BACK UNDER ANESTHESIA FOR SUTURING OF THE LACERATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? THE INTENDED PROCEDURE WAS FOR THE 15MM ENDOCATCH BAG TO BE FULLY DEPLOYED WHEN INITALLY UTILIZED AND WITH THE METAL TIPS BEING ENCAPSULATED BY THE PROPRIETARY RIP-STOP NYLON BAG. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION: THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT T

  Patient problems: Laceration(s)

  MAUDE report 23658000 ↗
• MalfunctionMar 22, 2024Fracture; Fracture

  DURING NEPHRECTOMY, HANDLE OUTSIDE THE BODY BROKE OFF MAKING IT DIFFICULT TO RETRIEVE THE SPECIMEN AND TO REMOVE THE METAL PART OF THE RETRIEVAL DEVICE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958850 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  INITIALLY REPORTED ON 9/28/2023 THAT THE DEVICE WAS BEING USED IN SURGERY, AND HANDLE PART BROKE OFF WHILE IN USE. THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC RADICAL NEPHRECTOMY. TROCAR SIZE WAS 15. THE BAG DID NOT CONTAIN SPECIMEN. THE HANDLE BROKE AT THE BEGINNING OF THE PROCEDURE. THE CUSTOMER SAID THEY WERE PULLING IN THE PRONGS SO THAT THE BAG COULD ENTER THE PATIENT AT THE BEGINNING OF THE SURGERY. ON 10/14/2023 A MEDSUN REPORT WAS RECEIVED VIA MAIL (UF/IMPORTER REPORT # (B)(4)) WHICH INDIACTED THAT THE HANDLE PORTION OF DEVICE OUTSIDE OF PT SNAPPED OFF WHILE THE BAG PORTION ON THE DEVICE WAS INSIDE THE PATIENT. ALL PARTS OF DEVICE WERE REMOVED FROM PATIENT AND A NEW DEVICE WAS OPENED AND USED. IT HAS BEEN DETERMINED THAT THE MEDSUN REPORT IS ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112904 ↗
• MalfunctionJul 6, 2023Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  DR. (B)(6), ASKED ME TO LET YOU KNOW THAT THE PMI SUPERBAG PNI2000 SHE USED YESTERDAY BROKE DURING DEPLOYMENT. ONE OF THE TINES BROKE THROUGH THE BAG, WHICH MADE IT DIFFICULT TO GET THE SPECIMEN INSIDE THE, NOW FLOPPY, OPENING OF THE BAG. THIS WAS ALSO DIFFICULT BECAUSE THE TINE WASN'T COVERED BY THE BAG AND INCREASED THE RISK OF INJURING PATIENT TISSUE. LUCKILY, THE PATIENT WASN'T HARMED DUE TO THIS BUT THE RISK WAS THERE. PER (B)(6), DR. (B)(6) WANTED THE MANUFACTURER TO KNOW THAT A PNI2000 SUPERBAG SHE USED BROKE DURING DEPLOYMENT. ONE OF THE TINES BROKE THROUGH THE BAG, WHICH MADE IT DIFFICULT TO GET THE SPECIMEN INSIDE THE NOW FLOPPY OPENING OF THE BAG. THIS WAS ALSO DIFFICULT BECAUSE THE TINE WASN'T COVERED BY THE BAG AND INCREASED THE RISK OF INJURING THE PATIENT TISSUE. THERE WAS NO PATIENT HARM, BUT THE DOCTOR FELT THAT THE RISK WAS THERE. WHERE EXACTLY ALONG THE LENGTH OF THE BAG MOUTH DID THE ARM COME THROUGH THE MATERIAL? (I.E. MID WAY, CLOSE TO THE INTRODUCER TUBE, CLOSE TO THE DISTAL END OF THE BAG). A: CLOSE TO THE DISTAL END OF THE BAG. HOW MANY TIMES WAS THE BAG USED? A: INCIDENT HAPPENED ON THE FIRST USAGE. WAS THE BAG ATTACHED TO THE ARM PRIOR TO RETRACTION INTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268900 ↗