Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG P-GRIP; LARYNGOSCOPE, RIGID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ SE & CO. KG P-GRIP; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 8548
Device Problems Energy Output Problem (1431); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2018
Event Type  malfunction  
Event Description
Using a mac 3 blade for intubating patient, the anesthesiologist was attempting to visualize the patient's airway.On placing the laryngoscope in the mouth and lifting the scope upwards, the light on the laryngoscope went out.Laryngoscope fail.Tested prior to patient use and it was functioning properly.Went to intubate and did not work.Got the 2nd laryngoscope out of the drawer and that one failed also.Laryngoscope worked when testing during room set up, failed when used to intubate patient.This has been happening more frequently.Of note, the scope light works correctly when upright and no pressure is applied to blade.However, when held in an inverted position and the blade is inserted in patient's mouth, the downward pressure on the blade seems to separate the electrical connection between blade and light carrier in the handle.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
P-GRIP
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
KARL STORZ SE & CO. KG
2151 e. grand avenue
el segundo CA 90245
MDR Report Key9238903
MDR Text Key163796569
Report Number9238903
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8548
Device Lot NumberYW2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2019
Event Location Hospital
Date Report to Manufacturer10/25/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2019
Type of Device Usage N
Patient Sequence Number1
-
-