SpyScope M00546230Recalls & reported problems
Boston Scientific Corporation · Access and Delivery Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729764434), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION SYSTEM WAS USED DURING A SPYGLASS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE FIBER WAS DIFFICULT TO ADVANCE AND THE CATHETER HAD FOREIGN MATTER WHICH BLOCKED THE VIEW OF THE DEVICE. THE FOREIGN MATTER COULD NOT BE CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYGLASS DIRECT VISUALIZATION SYSTEM. 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 STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6916793 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.