GastriSail GPS36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521517370), received between Jul 11, 2016 and Jun 15, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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.

• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED POST-OPERATIVELY FOLLOWING A LAPAROSCOPIC SLEEVE GASTRECTOMY. THE STOMACH WAS RESECTED USING THE GASTRIC POSITIONING SYSTEM. AN ADDITIONAL OPERATION WAS PERFORMED DUE TO THE FORMATION OF A STRICTURE. TO CORRECT THE ISSUE, THE SLEEVED STOMACH WAS DILATED. SURGICAL INTERVENTION WAS NECESSARY TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT LEAD TO OR EXTENDED PATIENT HOSPITALIZATION. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6643004 ↗
• MalfunctionJul 11, 2016Difficult To Position; Difficult to Remove; Retraction Problem; Difficult To Position; Difficult to Remove; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAP GASTRECTOMY, THE CRNA PLACED THE DEVICE WITH CM MARKINGS TO THE PATIENT LEFT BUT MINUTES LATER WHEN THE SURGEON INSTRUCTED HER TO DEPLOY THE SAIL, THE TUBE APPEARED TO DEPLOY TO THE GREATER CURVES RATHER THAT THE LIGHTED SAIL. SO, THE SAIL WAS RETRACTED AND THE CRNA ATTEMPTED TO ROTATE THE MAIN TUBE TO THE 9:00 POSITION AND REDEPLOY THE SAIL. BUT, IT WAS VISUALLY OBVIOUS THAT THE DISTAL END DID NOT LOOK CORRECT. SO, SHE ATTEMPTED TO RETRACT THE SAIL COMPLETELY BUT WAS UNABLE TO GET UP TO THE BLACK INDICATOR LINE. SHE THEN WAS INSTRUCTED BY THE SURGEON TO REMOVE THE ENTIRE DEVICE. SHE WAS UNABLE TO REMOVE DEVICE COMPLETELY DUE TO RESISTANCE. SHE THEN USED A LARYNGOSCOPE TO AID IN VIEWING THE DISTAL END OF THE DEVICE STILL IN THE BACK OF THE THROAT. SHE WAS ABLE TO FREE IT AND REMOVE THE DEVICE. THE LIGHTED SAIL HAD BEEN TIED IN A KNOT WHILE IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5783269 ↗