NA 72203360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554025897), received between Jan 16, 2018 and May 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2019Electrical Shorting

  IT WAS REPORTED THAT BEFORE CASE, THE DEVICE WAS NOT WORKING, IT WAS SHORTING OUT. NO PATIENT WAS INVOLVED

  Patient problems: No Patient Involvement

  MAUDE report 8644296 ↗
• MalfunctionJun 17, 2018No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD IMAGE FADES IN AND OUT WHEN THE CABLE IS MOVED, IT IS POSSIBLY A WIRING ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7608467 ↗
• MalfunctionJun 6, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WAS A DELAY WHEN PRESSING THE BOTTOM TO TAKE THE PICTURE. NO BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574094 ↗
• MalfunctionJan 16, 2018Circuit Failure

  IT WAS REPORTED THAT THE DEVICE SHORTED OUT WHEN IT WAS PLUGGED IN. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7198073 ↗

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