HD 1200 72203360Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010657497), received between Mar 8, 2018 and Feb 10, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING ACL KNEE SURGERY, BOTH CAMERA HEADS WERE NOT GIVING ANY IMAGE ON THE MONITOR DISPLAY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310661 ↗
• MalfunctionFeb 10, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING ACL KNEE SURGERY, THE BOTH CAMERA HEADS WERE NOT GIVING ANY IMAGE ON THE MONITOR DISPLAY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310613 ↗
• MalfunctionSep 3, 2019No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE SHUT DOWN DURING SURGERY. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8957891 ↗
• MalfunctionSep 3, 2019No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE SHUT DOWN. THERE WAS A LOSS OF IMAGE DURING THE PROCEDURE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8957863 ↗
• MalfunctionMar 8, 2018No Display/Image

  IT WAS REPORTED THAT THE DEVICE WAS BLACKING OUT, TURNED OFF BY IT SELF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323416 ↗

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