P-GRIP 8546Recalls & reported problems
Karl Storz GmbH & Co. KG · Handle Sleeve · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551210130), received between Dec 5, 2023 and Dec 5, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond2
- Break1
Patient problems
- Insufficient Information2
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING A PROCEDURE ON NOV-10-2023, THE DEVICE BROKE AND CUT THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18271380 ↗InjuryDec 5, 2023Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break
PER NEW INFORMATION PROVIDED BY THE CUSTOMER, THE DEVICE WAS USED FOR INTUBATION ON A MALE PATIENT (76.7 KG, 52 YEARS OLD) ON NOV-10-2023. THE DEVICE BROKE DURING THE INTUBATION AND CUT THE PATIENT'S LIP. INSTANT CARE WAS PROVIDED TO THE PATIENT RIGHT AFTER THIS HAPPENED. THERE IS NO LASTING IMPACT ON THE PATIENT ACCORDING TO THE CUSTOMER. THEY COMPLETED THE PROCEDURE WITH A BACK-UP UNIT, WITH A DELAY OF ABOUT FIVE MINUTES.
Patient problems: Insufficient Information; Laceration(s)
MAUDE report 18271377 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.