What you should know:
1. Devicemaker Pentax Medical informed the FDA of the issue in July. The report recently became public record.
2. Pentax said the hospital used up to four contaminated scopes in 998 procedures from 2018 through June 2019.
3. No patient infections have been reported to date.
4. The FDA redacted the name of the facility before releasing the reports publicly, its standard practice. Pentax and the Oklahoma State Department of Health would not identify the facility to Reuters.
5. Pentax said to Reuters that the hospital failed to properly follow the reprocessing instructions. The hospital notified all potentially affected patients.
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