1288 1288210105Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327063424), received between Dec 12, 2019 and Jun 12, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Poor Quality Image; Output Problem

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED IMAGE ISSUE. THEREFORE, THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487653 ↗
• MalfunctionFeb 21, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE AND COLOR DISTORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753444 ↗
• MalfunctionJan 13, 2023Fogging; No Display/Image; Fogging

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162282 ↗
• MalfunctionDec 16, 2022No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996550 ↗
• MalfunctionJun 30, 2022No Display/Image; Loss of Data; Loss of Data

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 14878384 ↗
• MalfunctionDec 21, 2021No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS RESCHEDULED. PLEASE NOTE, NO INCISIONS HAD BEEN MADE AT THE TIME OF RESCHEDULING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054605 ↗
• MalfunctionNov 17, 2021Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Electrical /Electronic Property Problem

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

  Patient problems: Electric Shock

  MAUDE report 12833261 ↗
• MalfunctionOct 14, 2021No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 12636544 ↗
• MalfunctionMar 11, 2021Intermittent Continuity; Intermittent Continuity; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING THE PROCEDURE.

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

  MAUDE report 11464069 ↗
• InjuryDec 16, 2019Erratic or Intermittent Display; Output Problem; Insufficient Device Problem Information; Erratic or Intermittent Display; Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WERE IMAGE ISSUES WHICH LED TO CONVERSION TO OPEN PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9476934 ↗
• MalfunctionDec 12, 2019Fogging; Fogging

  IT WAS REPORTED THAT THERE WAS FOGGING DURING A PROCEDURE, WHICH COULD NOT BE WIPED AWAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9459370 ↗

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-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-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-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