SUPERBAG PNI0750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10850013527622), received between Aug 6, 2025 and Nov 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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, 2025Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  DESCRIBE THE EVENT OR PROBLEM: DEVICE MALFUNCTION. THE BAG DIDN'T DEPLOY PROPERLY AND WE COULD NOT PUT A SPECIMEN INSIDE IT. ANOTHER BAG WAS USED AND IT WORKED AS EXPECTED. DEVICE IS AVAILABLE FOR RETURN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ROBOTIC VATS PROCEDURE. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659320 ↗
• MalfunctionOct 28, 2025Insufficient Device Problem Information

  DEVICE MALFUNCTION. NO DESCRIPTION OF ISSUE RELAYED TO REPORTER. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402129 ↗
• MalfunctionSep 5, 2025Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Insufficient Device Problem Information

  ENDOSCOPIC BASKET BROKEN -------------------------------------- WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : 1. FLEXIBLE BRONCHOSCOPY 2. LEFT VIDEO-ASSISTED THORACOSCOPY WITH LEFT LOWER LOBECTOMY [CPT 32663] 3. MEDIASTINAL AND REGIONAL LYMPH NODE DISSECTION [CPT +32674] 4. MULTILEVEL INTERCOSTAL NERVE BLOCKS. -------------------------------------- WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979600 ↗
• MalfunctionAug 6, 2025Break

  ENDOSCOPIC BASKET BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727989 ↗