SCOPE SAVER 000429Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20653405050282), received between Apr 10, 2017 and Mar 14, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN UPPER ENDOSCOPY PROCEDURE WITH THE 000429 BITE BLOCK RESULTED IN DAMAGE TO THE PATIENT'S DENTITION. ONE FRONT TOOTH FRAGMENTED OFF. THE REPORTER STATED THE TOOTH FRAGMENT DID NOT OCCUR DURING THE PROCEDURE OR HAD POTENTIAL FOR AN ADVERSE EVENT; IT WAS NOT DOCUMENTED HOW IT WAS RETRIEVED. THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THIS INCIDENT. UPON GATHERING ADDITIONAL INFORMATION, IT WAS NOTED THAT THE PATIENT HAD DENTAL HISTORY OF PARTIAL DENTURES AND POOR DENTITION. THE PATIENT WAS DISCHARGED HOME AND REQUIRED ADDITIONAL WORK ON AFFECTED TOOTH DUE TO THIS EVENT. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: Tooth Fracture

  MAUDE report 7337442 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN UPPER ENDOSCOPY PROCEDURE WITH THE 000429 BITE BLOCK RESULTED IN DAMAGE TO THE PATIENT'S DENTITION. THE FOUR TEETH IN THE LOWER FRONTAL REGION WERE NOTICED TO BE DISLODGED. THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THIS INCIDENT. UPON GATHERING ADDITIONAL INFORMATION, IT WAS NOTED THAT THE PATIENT HAD THE DENTAL HISTORY OF MISSING UPPER MOLARS BILATERALLY AND POOR DENTITION. THE PATIENT WAS DISCHARGED HOME AND REQUIRED ADDITIONAL WORK ON AFFECTED TEETH DUE TO THIS EVENT. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 7337388 ↗
• InjuryApr 10, 2017Failure To Unwrap; Failure To Unwrap

  THE USER FACILITY REPORTED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN NOTICED A FOREIGN BODY IN THE ESOPHAGUS. THE PHYSICIAN REMOVED THE SMALL PIECE OF PLASTIC WITH A ROTH NET DEVICE. THE FACILITY STATED "THE PLASTIC PIECE FIT EXACTLY INTO WHERE THE PACKAGING HAD BEEN TORN ON BITE BLOCK . THE BITE BLOCK PACKAGE HAD RIPPED OPEN BUT NOT ON DESIGNATED PERFORATED LINE." THERE WAS NO PATIENT OR USER INJURY WITH THIS REPORTED INCIDENT. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE. MULTIPLE ATTEMPTS FOR FURTHER INFORMATION HAS BEEN REQUESTED FROM USER FACILITY, BUT NONE HAS BEEN RECEIVED TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE INCLUDED IN THE SUPPLEMENTAL AND FINAL REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477052 ↗