GeniStrong 550-000-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00877972005186), received between Oct 24, 2019 and Aug 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  BAG BROKE DURING ROBOTIC LOBECTOMY. SEE PICTURE. ACCORDING TO INFORMATION OBTAINED BY REP, THE BAG BROKE WHILE THE SPECIMEN WAS INSIDE THE CHEST CAVITY AND THEY WERE TRYING TO PULL IT OUT. A 10 INCH INCISION WAS MADE ON PATIENT'S CHEST TO REMOVE SPECIMEN. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362739 ↗
• MalfunctionJul 9, 2020Material Integrity Problem; Material Integrity Problem

  SPECIMEN RETRIEVAL BAG BROKE WHILE REMOVING SPECIMEN FROM THE PATIENT DURING A LOBECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10253562 ↗
• MalfunctionOct 24, 2019Crack; Fitting Problem

  END OF THE DEVICE WAS CRACKED WHICH WOULDN'T ALLOW IT TO FIT INTO THE TROCAR. IT HAS TO BE ABLE TO PASS THROUGH THE TROCAR TO ENTER THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9232837 ↗