1488 1488010001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327061017), received between Aug 13, 2019 and Feb 16, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2022No Display/Image; Optical Problem; No Display/Image; Optical Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF IMAGE.

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

  MAUDE report 13544516 ↗
• InjuryDec 2, 2021Inappropriate/Inadequate Shock/Stimulation; Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE USER WAS SHOCKED.

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

  MAUDE report 12916053 ↗
• MalfunctionJan 21, 2021Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT THE USER WAS SHOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 11211349 ↗
• MalfunctionFeb 25, 2020Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge

  IT WAS REPORTED THAT A USER WAS SHOCKED.

  Patient problems: Shock

  MAUDE report 9750878 ↗
• MalfunctionAug 13, 2019Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF VISUALIZATION AND SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8888454 ↗

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