NA 72203361SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885554025880), received between Apr 20, 2018 and Apr 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).

1 other recall cover devices cleared under the same FDA submission (K014158); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2018Image Display Error/Artifact

  IT WAS REPORTED THAT THERE WAS NO PICTURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014158. One submission often covers many models, so check the product and lot details in each record.

• Z-0082-2012 · Sep 23, 2011 · Terminated
  Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories