Beacon DSA-090-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521722583), received between Jun 8, 2020 and Jul 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K180037); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 26, 2020Open, Classified

   This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

   Z-2768-2020 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryJul 13, 2020Difficult to Advance; Difficult to Advance

  ACCORDING TO THE REPORTER, THE PHYSICIAN TRIED TO GAIN ACCESS TO THE PATIENT'S COMMON BILE DUCT DURING THE RENDEZVOUS PROCEDURE BUT THEY COULD NOT PASS THE GUIDE WIRE THROUGH THE STRICTURE AND IT KEPT GOING TOWARD THE HILUM. THE PATIENT HAD A DISTAL BILIARY OBSTRUCTION WITH A COMMON DUCT DIAMETER OF AROUND 12 MM. THEY TRIED TO PUT THE STYLET BACK INTO THE CANNULA TO MAKE THE HOOK STRAIGHT AGAIN BEFORE REMOVING IT BUT WAS UNABLE TO INSERT CANNULA TO THE END. THE CANNULA WOULD NOT GO BACK INTO THE DEVICE AND THEY COULD NOT REMOVE WITHOUT THE TIP BEING HOOKED. THE INCIDENT OCCURRED ON FIRST PASS. ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WAS ATTEMPTED JUST PRIOR TO THE RENDEZVOUS ATTEMPT, BUT ERCP CANNULATION HAD FAILED. THE PHYSICIAN ALSO ATTEMPTED TO USE A 90 DEGREE ACCESS DEVICE, THE GUIDE WIRE INSERTED BUT IT AGAIN KEPT GOING INTO THE HILUM. THE GUIDE WIRE WAS REMOVED AND THE STYLET WAS RE-INSERTED PRIOR TO THE REMOVAL OF THE 90 DEGREE CATHETER. AT NO POINT DID THE GUIDE WIRE SUCCESSFULLY MAKE THE TURN AND PROCEED ANTEGRADE. THERE WAS NO IMMEDIATE COMPLICATIONS NOTED. A CT SCAN WAS PERFORMED THE FOLLOWING DAY AS PART OF PANCREATIC CA STAGING, AND BILIARY LEAK WAS IDENT

  Patient problems: No Code Available

  MAUDE report 10263884 ↗
• InjuryJun 8, 2020Premature Separation; Premature Separation

  ACCORDING TO THE REPORTER, THE TIP BROKE OFF IN THE DUODENUM. ABOUT 3 ATTEMPTS TO ACCESS THE DUCT WERE MADE. AFTER FIRST ATTEMPT, STYLET WAS WITHDRAWN, BUT THERE WAS NO CLEAR "HOOK" OF THE CANNULA APPRECIATED VISUALLY. THE STYLET WAS REINSERTED. THE NEEDLE WAS REPOSITIONED ABOUT 1 OR 2 MORE TIMES BUT AT NO POINT WAS THE HOOK OF THE CANNULA IDENTIFIED VISUALLY. ON ABOUT THE THIRD ATTEMPT, THE PHYSICIAN ZOOMED IN ON FLUORO AND NOTICED THAT THE STYLET WAS EXTENDING ROUGHLY 1CM BEYOND THE CANNULA. THE PHYSICIAN NOTICED THAT THE TIP MAY HAVE BROKEN OFF AND REMOVED THE DEVICE. ANOTHER DEVICE WAS USED WITH NO ISSUE AND THE GUIDEWIRE WAS PLACED ANTEGRADE INTO THE DUODENUM. BROKEN PORTION OF THE CANNULA WAS FOUND IN THE DUODENUM PRIOR TO COMPLETION OF THE RENDEZVOUS AND IT WAS RETRIEVED. THERE WERE NO FOREIGN MATERIALS THAT REMAINED INSIDE THE PATIENT'S BODY. NO TRAUMA WAS NOTED TO THE GUIDEWIRE, BUT THE GUIDEWIRE TIP APPEARED TO HAVE GOTTEN STUCK SUPERFICIALLY IN THE WALL OF THE DUODENUM AFTER PASSING THROUGH THE AMPULLA. THE STRICTURE WAS DILATE D, AND A STENT WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE, AND NO HEALTH COMPLICATIONS WERE NOTED AS A RESULT OF THE DEVICE BREAK. THE PATIE

  Patient problems: Injury

  MAUDE report 10128652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180037. One submission often covers many models, so check the product and lot details in each record.

• Z-2769-2020 · Jun 26, 2020 · Open, Classified
  Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-sha