FILBLOC PERMANENT PLY-G02-020-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18033439178889), received between Apr 4, 2024 and Dec 23, 2024 — classified as 2 malfunctions.

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

• MalfunctionDec 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A GASTRIC FISTULA REPAIR PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE OVERSTITCH NXT IS ASSEMBLED AS SHOWN IN THE TRAINING. AFTER MAKING THE FIRST STITCH IN THE GASTRIC MUCOSA, AN ATTEMPT IS MADE TO MAKE A SECOND STITCH, BUT THE SPACE IS VERY SMALL AND ALMOST PREVENTS THE MOVEMENT AND VISION OF THE ENDOSCOPE. AFTER SEVERAL ATTEMPTS TO ADJUST THE POSITION (MOVING THE ENDOSCOPE) TO BE ABLE TO WORK AND ESPECIALLY TO HAVE VISION, WE SEE THE DARK PART OF THE ENDCAP ON THE SCREEN AND UNDERSTAND THAT THAT PART HAS BEEN WELDED/LOOSENED. AFTER RELEASING THE NEEDLE AND CLOSING THE SYSTEM TO BE ABLE TO EXIT WITH MAXIMUM SAFETY, THE NEEDLE REMAINS TRAPPED IN THE SYSTEM, CAUSING A NEW COMPLICATION. FINALLY, THE THREAD-NEEDLE UNION BREAKS, AND WE CAN LEAVE, VERIFYING THAT, INDEED, THE FINAL PART HAS COMPLETELY COME OUT OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH A FULLY COVERED ESOPHAGEAL PROSTHESIS DUE TO THE LACERATION PRODUCED AND SUBSEQUENT BLEEDING. PATIENT FULLY RECOVERED FROM THE EVENT AND ANOTHER SURGERY HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21001553 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2024 THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM THAT TWO SUTURES WENT WRONG DURING THE COURSE OF THE PROCEDURE. DURING THE PROCEDURE, WHEN PREFORMING THE SECOND SUTURE, THE FIRST SUTURE BROKE AS THE THREAD CAME OUT OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE, AND THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040030 ↗