Multibite M00510100Recalls & reported problems
Boston Scientific Corporation · Single-Use Biopsy Forceps · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729745198), received between Nov 5, 2019 and Nov 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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
- Human-Device Interface Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2019Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MULTIBITE BIOPSY FORCEPS WAS USED IN THE ESOPHAGUS DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT HAD A HISTORY OF DYSPHAGIA ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT'S MUCOSA WAS NOTED TO BE SOFT AND WAS TORN UPON INSERTION OF THE SCOPE. WHEN THE MULTIBITE FORCEPS WERE PUSHED UP AGAINST THE DISTAL ESOPHAGUS, THEY PUNCTURED THROUGH THE ESOPHAGUS CREATING A 3-4 MM HOLE. THE PERFORATION WAS CLIPPED CLOSED AND THE PROCEDURE WAS COMPLETED WITH A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 DUE TO THE PERFORATION.
Patient problems: Perforation
MAUDE report 9282624 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
- Radial Jaw 4 M00513410Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.