1288 1288010000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327063387), received between Dec 28, 2018 and Nov 8, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Electrical Power Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K132785); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Smoking; Temperature Problem; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755297 ↗
• MalfunctionJun 13, 2022Smoking; Smoking

  IT WAS REPORTED THAT THE DEVICE WAS SMOKING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14679357 ↗
• MalfunctionApr 28, 2022Optical Problem; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240335 ↗
• MalfunctionJan 12, 2022Poor Quality Image

  IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237719 ↗
• MalfunctionDec 1, 2021Inappropriate/Inadequate Shock/Stimulation; Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE USER WAS SHOCKED. PLEASE NOTE, IT WAS CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES.

  Patient problems: Electric Shock

  MAUDE report 12909266 ↗
• MalfunctionAug 26, 2020No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10457368 ↗
• MalfunctionDec 28, 2018Electrical Power Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132785. One submission often covers many models, so check the product and lot details in each record.

• Z-0569-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video
• Z-0570-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monit
• Z-0571-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video