1488 1488010000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327061024), received between Oct 30, 2018 and May 14, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025No Display/Image; Overheating of Device; Output Problem; Temperature Problem; No Display/Image; Overheating of Device; Output Problem; Temperature Problem

  IT WAS REPORTED THAT THE CAMERA STOPPED WORKING DURING THE PROCEDURE, THERE WAS A SMELL OF BURNED PLASTIC IN THE AIR.

  Patient problems: Insufficient Information

  MAUDE report 22023599 ↗
• MalfunctionFeb 22, 2023Connection Problem; Output Problem; Connection Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 16420492 ↗
• MalfunctionSep 15, 2022Fogging; Fogging; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 15426880 ↗
• MalfunctionMay 25, 2022Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT THERE WAS ELECTRIC SHOCK TO THE USER.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493172 ↗
• MalfunctionMay 19, 2022Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT THERE WAS ELECTRIC SHOCK TO THE USER.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434482 ↗
• InjuryNov 16, 2021Electrostatic Discharge; Electrostatic Discharge

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824823 ↗
• MalfunctionMar 5, 2021No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 11422592 ↗
• MalfunctionDec 21, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 11048015 ↗
• MalfunctionDec 21, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 11047921 ↗
• MalfunctionDec 21, 2020No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: Insufficient Information

  MAUDE report 11047915 ↗
• MalfunctionOct 29, 2020Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS FOR THREE MINUTES.

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

  MAUDE report 10756270 ↗
• MalfunctionOct 29, 2020Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 10756206 ↗
• MalfunctionOct 29, 2020Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS FOR THREE MINUTES.

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

  MAUDE report 10756171 ↗
• MalfunctionJul 2, 2020Use of Device Problem; No Display/Image; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10224996 ↗
• MalfunctionAug 13, 2019No Display/Image

  IT WAS REPORTED THAT THERE WAS A LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8888449 ↗
• MalfunctionAug 13, 2019No Display/Image

  IT WAS REPORTED THAT THERE WAS A LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8888444 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE DUE TO THE PATIENT'S ANATOMY.

  Patient problems: No Information

  MAUDE report 8021923 ↗

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-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
• 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