Beacon DSN-22-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00855208005018), received between Jun 10, 2019 and Jan 14, 2025 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K103668); 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD A CASE OF SEVERE BLEEDING AND PANCREATITIS AFTER A FINE NEEDLE BIOPSY AND FINE NEEDLE ASPIRATION PROCEDURES FOR CYST ASPIRATION, CYST ASPIRATION WITH SOLID COMPONENTS, AND SOLID MASS TISSUE SAMPLE, AND ONE PATIENT DIED AS A RESULT OF THE COMPLICATION USING FINE NEEDLE ASPIRATION NEEDLE. PATIENT WAS ADMITTED THE DAY AFTER BEACON FNA PROCEDURE DUE TO FULMINANT ACUTE PANCREATITIS. PATIENT DIED THE FOLLOWING DAY AFTER ADMITTED, WITH MULTI-ORGAN FAILURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21152969 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) 22G 2 PASSES, PATIENT HAD BLEEDING WITH CLIPS AND ADRENALINE USED FOR MANAGEMENT. INTRALUMINAL BLEEDING, INTRA-PROCEDURAL HEMOSTASIS WITH 1:20,000 ADRENALINE SOLUTION 4ML AND 2 CLIPS. PATIENT FINAL DIAGNOSIS HEAD PANCREATIC SOLID-CYSTIC MIXED 3, 2CM LESION-MICROCYSTIC ADENOMA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137984 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) AND FINE NEEDLE ASPIRATION (FNA) PROCEDURE, A PATIENT HAD A COMPLICATION OF PANCREATITIS AND SEVERE BLEEDING WHICH LED TO EXTENDED HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137869 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.

  Patient problems: Sedation

  MAUDE report 8701877 ↗
• MalfunctionJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.

  Patient problems: Respiratory Distress

  MAUDE report 8685024 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.

  Patient problems: Bradycardia

  MAUDE report 8685016 ↗
• InjuryJun 10, 2019Break; Break

  ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.

  Patient problems: No Code Available

  MAUDE report 8684991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103668. One submission often covers many models, so check the product and lot details in each record.

• Z-1474-2017 · Feb 8, 2017 · Terminated
  SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
• Z-1476-2017 · Feb 8, 2017 · Terminated
  BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
• Z-1473-2017 · Feb 8, 2017 · Terminated
  SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
• Z-1472-2017 · Feb 8, 2017 · Terminated
  BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
• Z-1475-2017 · Feb 8, 2017 · Terminated
  SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01