Injection Gold Probe M00560160Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729056508), received between Jan 12, 2017 and Sep 1, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534789 ↗
• InjuryMar 16, 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 AN INJECTION GOLD PROBE NEEDLE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL GOLD TIP OF THE NEEDLE DETACHED AND FELL INTO THE PATENT'S STOMACH. A RAT TOOTH FORCEPS WAS USED TO RETRIEVE THE DETACHED DISTAL GOLD TIP AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR INJECTION GOLD PROBE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554799 ↗
• MalfunctionMar 25, 2022Output Problem

  THE PROBE DID NOT BURN. NEW PROBE WAS FROM A DIFFERENT LOT WAS OPENED. THE PRODUCT PERFORMED AS INTENDED AND NO FURTHER INTERVENTION WAS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 13901017 ↗
• MalfunctionMar 2, 2022Therapeutic or Diagnostic Output Failure

  DURING AN EGD PROCEDURE, THE PROBE WAS NOT FUNCTIONING AS REQUIRED AFTER ALL SETTINGS AND MACHINERY WAS CHANGED.

  Patient problems: Insufficient Information

  MAUDE report 13653271 ↗
• MalfunctionMar 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ADVANCED A GOLD PROBE DOWN THE SCOPE. THEY TRIED TO ACTIVATE THE PROBE BUT NO ENERGY WAS GETTING TO THE TIP OF THE PROBE. THEY REMOVED THE PROBE AND USED ANOTHER ONE, OF A DIFFERENT LOT NUMBER. WHILE ADVANCING DOWN THE SCOPE, AND THE TIP OF THE PROBE FELL OFF INSIDE THE SCOPE. THEY RETRIEVE THE DETACHED PIECE FROM THE SCOPE USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED USING A THIRD INJECTION GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785170 ↗
• MalfunctionMar 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE DUODENUM DURING AN EMERGENT GI BLEED PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE INJECTION GOLD PROBE WAS BROKEN INSIDE THE PACKAGE. THE COMPLAINANT PROVIDED A PHOTO OF THE DEVICE, WHICH SHOWS THE DISTAL TIP WAS DETACHED. THIS WAS DISCOVERED DURING THE PROCEDURE, WHILE THE DEVICE WAS DOWN THE SCOPE AND INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438573 ↗
• MalfunctionJun 14, 2017Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE UPPER GI DURING A HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INJECTION GOLD PROBE FAILED TO CAUTERIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639709 ↗
• MalfunctionJun 1, 2017Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INJECTION GOLD PROBE FAILED TO CAUTERIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6605172 ↗
• MalfunctionJan 12, 2017Material Puncture/Hole; Material Separation; Material Puncture/Hole; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN EVENT OCCURRED WITH AN INJECTION GOLD PROBE¿ WITH AN WHILE BEING USED IN THE COLON DESCENDENS DURING A PROCEDURE PERFORMED ON (B)(6) 2016. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. THE INVESTIGATION FOUND THE DISTAL TIP OF THE GOLD PROBE WAS DETACHED, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6248148 ↗