BrachySource™, SourceCap™ 1251CSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741078248), received between Jan 30, 2018 and Aug 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SEED ALLEGEDLY WOULD NOT EJECT PROPERLY. THEREFORE, THAT ONE CLOGGED SEED COULD NOT BE USED FOR TREATMENT, HOWEVER, IT DID NOT AFFECT TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365060 ↗
• MalfunctionJan 30, 2018Device Inoperable; Failure to Deliver; Device Operates Differently Than Expected; Device Inoperable

  IT WAS REPORTED THAT THE SEEDS WERE NOT DISPENSING FROM THE CARTRIDGE PROPERLY. THE COMPLAINANT REPORTED THAT THE SOURCES WERE NOT DROPPING INTO THE MICK AND WERE THEN GETTING BUNCHED UP AND GOING EVERYWHERE. SEEDS WERE REPORTEDLY FOUND ON THE OR TABLE AND ON THE FLOOR AT THE END OF THE CASE. THE COMPLAINANT REPORTED THAT THE IMPLANT WAS "COMPLETED WITH FULL DOSAGE AND NORMAL, EXPECTED OUTCOME." ONE FAULTY CARTRIDGE WILL BE RETURNED WITH LEFTOVER SEEDS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7227228 ↗