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Gold Probe M00560070Recalls & reported problems

Boston Scientific Corporation · Bipolar Electrohemostasis Catheter · Class 2

All models of Gold Probe (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Boston Scientific Gold Probe bipolar electrohemostasis catheter is used to stop bleeding during endoscopy. Most of its 44 reports describe the gold tip breaking or detaching from the catheter, sometimes falling into the patient and needing retrieval with a net or rat-tooth forceps, plus a few cases where the device did not deliver energy. Thirteen reports involve injuries and none involve deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
43
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729174691), received between Nov 15, 2016 and Sep 24, 2026 — classified as 12 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 3 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 3 reportsOct 2025: 3 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component26
  • Failure to Deliver Energy9
  • Adverse Event Without Identified Device or Use Problem5
  • Detachment Of Device Component2
  • Material Separation2
  • Use of Device Problem2
  • Component Missing1
  • Inability to Irrigate1

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • No Consequences Or Impact To Patient14
  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

  • InjurySep 24, 2026Detachment of Device or Device Component

    It was reported to Boston Scientific Corporation that a Gold Probe was intended to be used for a Hemostasis during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026. During the procedure, the device exhibited a condition where the gold tip of the gold probe fell off the catheter after electrocoagulation. The distal gold tip fell into the patient. The physician grabbed the gold tip of the probe out with the use of a forceps. The procedure was completed with the original device.The patient condition following the procedure was reported as stable, and no patient complications were reported as a result of this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50887081 ↗
  • MalfunctionFeb 13, 2026Inability to Irrigate; Nonstandard Device

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE HEMOSTASIS CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS REPORTED THAT THERE IS NO WATER FLOW THROUGH THE CHANNEL, WHICH COMPROMISES THE PROPER USE OF THE DEVICE. ALSO, A VISUAL IRREGULARITY WAS OBSERVED AT THE TIP OF THE ELECTRODE, AS WELL AS A SLIGHTLY YELLOWISH APPEARANCE OF THE MATERIAL. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24332299 ↗
  • InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GOLD PROBE FELL OFF IN THE PATIENT. THE TIP OF THE DEVICE WAS RETRIEVED USING A RAT TOOTH. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 10, 2025. THE ANATOMY LOCATION WAS COLON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23489638 ↗
  • MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO 3005099803-2025-05331 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE SNAPPED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23321534 ↗
  • MalfunctionOct 17, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    NOTE: THIS REPORT PERTAINS TO TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05330 FOR THE FIRST GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE SNAPPED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23321523 ↗
  • MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ENTIRE DISTAL GOLD TIP DETACH FROM THE END OF THE CATHETER BUT DIDN'T FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23293858 ↗
  • MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A HEMOSTASIS PROCEDURE ON (B)(6), 2025. DURING THE PROCEDURE, THE TIP FELL OFF IN PATIENT AND GET DETACHED FROM THE END OF THE CATHETER. IT WAS RETRIEVED USING THE NET. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22993111 ↗
  • MalfunctionSep 8, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A HEMOSTASIS PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP FELL OFF IN PATIENT AND GET DETACHED FROM THE END OF THE CATHETER. IT WAS RETRIEVED USING THE NET. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22993110 ↗
  • InjurySep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE DUODENUM DURING HEMOSTASIS PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP BECAME SEPARATED. THE TIP WAS RETRIEVED USING TISSUE CLIPS. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22955813 ↗
  • InjuryJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DEVICE WAS USED TO CAUTERIZE, AND THE DISTAL GOLD TIP DETACHED INSIDE THE PATIENT. A NON-BSC RETRIEVAL DEVICE WAS USED TO RETRIEVE THE TIP. ANOTHER GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22202667 ↗
  • MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER: 3005099803-2024-06777 FOR THE FIRST GOLD PROBE, AND 3005099803-2024-06778 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GOLD PROBE DEVICES WERE USED DURING AN UPPER GI ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE DISTAL TIP OF THE TWO GOLD PROBE NEEDLES BROKE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21102855 ↗
  • MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-06778 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GOLD PROBE DEVICES WERE USED DURING AN UPPER GI ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE DISTAL TIP OF THE TWO GOLD PROBE NEEDLES BROKE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21102823 ↗
  • MalfunctionDec 13, 2024

    TWO DIFFERENT GOLD PROBE ELECTRICAL CONNECTORS: THE TIPS BROKE OFF --OUTSIDE OF THE PATIENT. 1. LOT# 34679528, EXP. 8/21/2026. 2. LOT# 33590221, EXP. 3/8/2026.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20924285 ↗
  • InjurySep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A SMALL BOWEL ENTEROSCOPE PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE DISTAL TIP DETACHED FROM THE WORKING LENGTH. THE DISTAL TIP WAS RETRIEVED WITH A BIOPSY FORCEPS AND ANOTHER GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20304177 ↗
  • InjurySep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP BROKE OFF DURING GOLD PROBE USAGE WITHIN A PATIENTS STOMACH. THE TIP WAS ABLE TO RETRIVE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20200154 ↗
  • MalfunctionSep 11, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A BRONCHOSCOPY PROCEDURE TO CONTROL BLEEDING ON AN UNKNOWN DATE IN (B)(6) 2024. WHEN THE DEVICE WAS REMOVED FROM THE BRONCHOSCOPE, THE TIP OF THE GOLD PROBE WAS MISSING. THE BRONCHOSCOPE WAS REINSERTED INTO THE PATIENT AND THE BROKEN TIP WAS VISUALIZED. THE DETACH TIP WAS RETRIEVED USING THE SUCTION FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE DEVICE WAS REPORTED TO BE USED DURING A BRONCHOSCOPY PROCEDURE; HOWEVER, THE IFU DOES NOT LIST THIS ANATOMY AS AN INDICATION. THE GOLD PROBE IFU STATES, "THE GOLD PROBE CATHETER AND THE GOLD PROBE 350CM CATHETER ARE INDICATED FOR USE IN TRANSENDOSCOPIC ELECTROHEMOSTASIS OF VISIBLE BLEEDING AND NON-BLEEDING SITES IN THE GASTROINTESTINAL TRACT INCLUDING THE ESOPHAGUS, STOMACH, DUODENUM, AND COLON".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20196894 ↗
  • MalfunctionAug 19, 2024

    BOSTON SCIENTIFIC= GOLD PROBE USED FOR CAUTERY WAS DEPLOYED IN A PATIENT'S AIRWAY DURING BRONCHOSCOPY PROCEDURE TO CONTROL BLEEDING. WHEN PROBE WAS REMOVED FROM THE BRONCHOSCOPE WE BECAME AWARE THE TIP WAS MISSING FROM THE INSTRUMENT. PHYSICIAN IMMEDIATELY WENT BACK TO THE AREA WHERE IT WAS USED LAST. VISUALIZED THE BROKEN TIP AND RETRIEVED IT INTACT WITH SUCTION THROUGH THE SCOPE THUS REMOVING IT FROM THE PATIENT'S AIRWAY WITH NO HARM OR LASTING EFFECTS TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19999660 ↗
  • MalfunctionJul 26, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN USED A GOLD PROBE TO CONTROL BLEEDING. WHEN THE DEVICE WAS REMOVED FROM THE SCOPE, THE TIP WAS CLEANED OFF AND DETACHED FROM THE CATHETER. ANOTHER GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19838105 ↗
  • MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE NEEDLE WAS USED IN THE DUODENUM DURING A GASTROSCOPY PROCEDURE PERFORMED ON MAY 30, 2023. DURING THE PROCEDURE, IT WAS REPORTED THAT UPON WITHDRAWING THE DEVICE, THE PHYSICIAN NOTICED A SMALL PIECE CAME OFF THE DISTAL END OF THE DEVICE AND WAS LEFT IN THE PATIENT. THE PHYSICIAN WAS NOT CONCERNED ABOUT THE DETACHED PIECE INSIDE THE PATIENT AND NO RETRIEVAL WAS ATTEMPTED. THE PROCEDURE WAS SUCCESSFULLY ENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17261488 ↗
  • MalfunctionMay 19, 2023Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE NEEDLE WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6)2023. DURING PREPARATION, THE ENTIRE GOLD TIP DETACHED FROM THE END OF THE CATHETER WHEN THE NEEDLE TIP WAS BEING CLEANED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. IT IS UNKNOWN IF ANOTHER OF THE SAME DEVICE WAS USED OR A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16966180 ↗
  • MalfunctionFeb 3, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE LYMPH NODE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE BROKE. IT WAS REPORTED THAT THE DEVICE DETACHED; HOWEVER, IT IS UNKNOWN AT THIS TIME WHAT SPECIFICALLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16292672 ↗
  • MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GOLD PROBE HAD A HARD TIME INJECTING. THEY PULLED IT OUT TO WIPE AND THE DISTAL GOLD TIP DETACHED FROM THE CATHETER EXPOSING THE WIRES. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15680626 ↗
  • MalfunctionDec 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE HEMOSTATIS CATHETER WAS USED IN THE DURING A GASTROINTESTINAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE GOLD PROBE NEEDLE WAS REMOVED FROM THE PACKAGING TO TREAT THE PATIENT. UPON REMOVAL, THE DEVICE TIP FELL OFF AND ON TO THE FLOOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE HEMOSTATIS CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12919099 ↗
  • InjuryApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE STOMACH DURING A HEMOSTASIS OESOPHAGOGASTRODUODENOSCOPY (OGDS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE DETACHED FROM THE CATHETER AND FELL INTO THE PATIENT. THE TIP WAS REMOVED USING A ROTH NET. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11675251 ↗
  • InjuryFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE DOUDENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST GOLD PROBE TIP FELL OFF AND THE SAME HAPPENED TO THE SECOND NEEDLE AFTER APPLYING GOLD PROBE TO BLEEDING AMPULLA. THE TIP WAS RETRIEVED BY PULLING THROUGH SCOPE WITH RAT TOOTH/ALLIGATOR FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11306875 ↗

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