SOLOBAG PPI0280Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850013527790), received between Feb 23, 2026 and Feb 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Use of Device Problem; No Apparent Adverse Event

  ON (B)(6) 2026 AT 1545 DURING ROBOTIC CHEST EXPLORATION, HEMATOMA EVACUATION SURGERY, THERE WAS A CLEAR CYLINDRICAL OBJECT NOTED IN THE CHEST CAVITY. THE SURGEON REMOVED THE OBJECT AND IT WAS IDENTIFIED AS A CLEAR STRING GUIDE FROM THE PMI SOLOBAG, ITEM PPI0280, LOT 2501020. SIX BAGS WERE USED DURING PROCEDURE, WITH ALL 12 STRING GUIDES LOCATED AND COUNTED. RISK MANAGER MET WITH OR MANAGER, FIRST ASSIST, AND RN TO REVIEW EVENT, AND NOTED THE FOLLOWING: THIS IS A "NEW"/DIFFERENT PRODUCT THAN THE PREVIOUS SPECIMEN RETRIEVAL SYSTEM THAT WAS USED. THE STRING GUIDE (LOOKS LIKE A CLEAR DULL YELLOW BEAD ABOUT 1/4 INCH IN SIZE) WAS DISLODGED FROM THE DEPLOYMENT SECTION OF THE DEVICE. WHEN THE STRING WAS CUT TO RETRIEVE THE SPECIMEN FROM THE SPECIMEN BAG, THE BEAD, WHICH GENERALLY STAYS IN THE DEPLOYMENT SECTION (A "STOP" FOR THE BAG DEPLOYMENT), WAS ON THE STRING AND FELL OFF THE STRING AND INTO SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421919 ↗