Beacon DSA-135-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521663527), received between Apr 1, 2020 and Jul 10, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 26, 2020Class IIOpen, 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-2769-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 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 10260212 ↗
• InjuryJun 15, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE OFF INTO THE PATIENT'S STOMACH. THE PATIENT HAD A MALIGNANT PANCREATIC MASS INVOLVING THE PROXIMAL DUODENUM AND COMPRESSED THE MID COMMON BILE DUCT (CBD) AND PORTAL VEIN. SINCE THE DUODENUM COULD NOT BE REACHED WITH THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND THEY USED RENDEZVOUS AND PLANNED ON COMPLETING PROCEDURE WITH AN ESOPHAGOGASTRODUODENOSCOPY. THEY USED A DISTAL ANTRUM AS ACCESS POINT WHICH GIVES A SIMILAR VIEW AS THE DUODENAL BULB. THEY FIRST USED THE 90 NEEDLE WHICH WORKED WELL AND THE WIRE COULD NOT BE ADVANCED INTO THE COMMON BILE DUCT AND KEPT GOING INTO THE INTRAHEPATIC'S AND GIVEN FINDINGS OF 135 WOULD GAVE THEM A BETTER ANGLE. THE 90 WAS REMOVED UNEVENTFULLY AND THEN USED THE 135. INITIALLY THE WIRE WENT INTO THE INTRAHEPATIC'S. THEY THEN ROTATED IT 180 DEGREES OR SO WITHOUT ANY ISSUES AND WIRE WENT INTO THE COMMON BILE DUCT AS STANDARD (AND WIRE WAS PASSED THROUGH AMPULLA). THE PHYSICIAN PULLED THE NEEDLE INTO THE SCOPE AND IT DID NOT LEAVE ITS POSITION. THERE WAS NO RESISTANCE OR ABNORMAL SOUNDS HEARD OR FELT. IT WAS NOTED THAT THE NEEDLE WAS BROKEN AS THEY COULD STILL SEE IT ON THE DEVICE AND AFTER WHOL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10153701 ↗
• MalfunctionApr 9, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, THE DEVICE SNAPPED IN HALF DURING THE PROCEDURE. THE HANDLE IS BROKEN SEEMED TO HAVE OCCURRED ON/AROUND THE TIME OF THE FIRST PASS ATTEMPTING TO ENTER THE BILE DUCT. AFTER IT BROKE, IT WAS DIFFICULT TO REMOVE IT FROM THE SCOPE AND IT SEEMED THAT A WRENCH WAS USED. THE CUSTOMER HAD TO CHANGE OUT THE SCOPE AND SWITCH TO A DIFFERENT MODALITY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE THAT IT WAS A BROKEN HANDLE AND NOT A BROKEN CANNULA TIP. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942623 ↗
• InjuryApr 1, 2020Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DISTAL PORTION OF THE CANNULA BROKE OFF AND REMAINED IN PATIENT. THE PROCEDURE WAS ATTEMPTED WITH A 135 DEGREE CATHETER USING A DUCT THAT HAD AN ESTIMATED SIZE OF ABOUT 12-14 MM AND UEUS SCOPE. THE NEEDLE TIP WENT IN AND THERE WERE SOME REDUCED VISIBILITY AFTER THE STYLET WAS REMOVED WHICH THEY THOUGHT IT WAS RELATIVELY NORMAL OR EXPECTED. THE CONTRAST WAS INJECTED AND THERE WERE SOME LEAKAGE OF CONTRAST OUTSIDE THE DUCT WHICH WAS LIKELY FROM THE TOP FENESTRATION. THE STYLET WAS PUSHED BACK IN FOR POSITION ADJUSTMENT BUT THERE WAS RESISTANCE FROM ABOUT 10 CM BEFORE IT WOULD HAVE BEEN HUBBED. THE ATTEMPTED ADJUSTMENT SEEMED UNSUCCESSFUL SO THE PHYSICIAN DECIDED TO PULL THE CANNULA BACK INTO THE SCOPE. AFTER THAT, THE STYLET WAS SUCCESSFULLY REINSERTED. THE DEVICE WAS REMOVED FROM THE SCOPE AND THEY NOTICED AN ABNORMAL APPEARANCE OF THE DISTAL TIP. APPROXIMATELY 90-95% OF THE FENESTRATED END SHEERED OFF INTO THE DUCT WITH A SOMEHOW HORSESHOE SHAPE. THE CUSTOMER STATED THAT MOTIONS WERE CAREFUL WITH THE SCOPE AND THERE WAS NOT MUCH ROTATION OF THE CANNULA DURING THE PROCEDURE, JUST A MM OR TWO. THE PHYSICIAN WAS UNCERTAIN AS TO WHAT POINT OF THE PROCEDUR

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Pain

  MAUDE report 9909014 ↗

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-2768-2020 · Jun 26, 2020 · Open, Classified
  Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shap