GIBI HD B-2036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850007764227), received between Nov 3, 2022 and Nov 3, 2022 — 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.

• MalfunctionNov 3, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTIES WITH RETRIEVING THE GASTROINTESTINAL BOUNDARY IDENTIFIER (GIBI) HD GASTRIC TUBE DURING SURGERY. DURING THE PRIMARY LAPAROSCOPIC GASTRIC BYPASS, THE GIBI GASTRIC TUBE SIZE 36 FR WAS UTILIZED AS A GUIDE TO SIZE THE STOMACH POUCH AND ROUX LIMB. FOLLOWING THE CREATION OF THE STOMACH POUCH, THE TUBE WAS ADVANCED INTO THE JEJUNUM AND WAS USED AS A SIZING GUIDE TO CREATE THE GASTROJEJUNAL ANASTOMOSIS. THE TUBE'S SOFT TIP AND BALLOON WERE POSITIONED DISTALLY TO THE ANATOMOSIS SITE BEFORE SUTURE WAS MADE. UPON THE COMPLETION OF THE GASTROJEJUNAL ANASTOMOSIS, THE SURGEON ATTEMPTED TO RETRIEVE THE GASTRIC TUBE BY PULLING IT PROXIMALLY; HOWEVER, THE TUBE HAD DIFFICULTY PASSING THROUGH THE SUTURED GASTROJEJUNAL ANASTOMOSIS. THE SUTURE WAS LOOSENED TO ALLOW THE TUBE RETRIEVAL. THE SITE WAS RESUTURED. ENDOSCOPY WAS USED TO IDENTIFY AND REPAIR ANY LEAKAGE. DUE TO THE DIFFICULTY OF TUBE RETRIEVAL, THE SURGERY WAS EXTENDED. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15720548 ↗