Performer G08550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002085503), received between Aug 7, 2017 and Jul 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionJul 17, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, THE TIP OF THE PERFORMER INTRODUCER WAS NOTED TO BE DAMAGED WHEN IT WAS REMOVED FROM IT'S PACKAGING. THE DAMAGE WAS DESCRIBED AS A ROUGH END WITH SHARP EDGES. THE DEVICE WAS NOT USED DURING THE UNSPECIFIED PROCEDURE. ANOTHER PERFORMER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED. REPORTEDLY, THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD IT BE RECEIVED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695700 ↗
• MalfunctionAug 7, 2017Defective Component; Split

  PRIOR TO USE, THE COMPLAINANT NOTED THAT THE TIP WAS "DEFECTIVE". IT WAS FURTHER NOTED THAT THE DILATOR TIP WAS SPLIT.

  Patient problems: No Patient Involvement

  MAUDE report 6772271 ↗