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 ENDOFLATOR 50; LAPAROSCOPIC GAS DISTENSION SYSTEM
  • 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 ENDOFLATOR 50; LAPAROSCOPIC GAS DISTENSION SYSTEM Back to Search Results
Model Number UI500
Device Problems Use of Incorrect Control/Treatment Settings (1126); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
Device is currently under investigation at the factory.
 
Event Description
As per a manufacturer incident report we received from the factory in (b)(4): as reported: "error 371- too low input pressure- patient got a too low heart rate and had to be reanimated".
 
Manufacturer Narrative
As per manufacturer evaluation findings: upon evaluation, we found that the co2-gas supply of the device is set to 'bottle' but the user uses a central gas supply.After clarification with the customer, it was confirmed that the central supply is used in the hospital.Therefore, the device shows everytime that the pressure is too low (message 371), like the user described it.No error occured during the device endurance test in the climate chamber for 48h.The overpressure detection and the pressure relief is working properly.The reason for the patient's heart rate becoming too low and why they had to reanimate him couldn't be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOFLATOR 50
Type of Device
LAPAROSCOPIC GAS DISTENSION SYSTEM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
MDR Report Key11334627
MDR Text Key232085373
Report Number9610617-2021-00017
Device Sequence Number1
Product Code FCX
UDI-Device Identifier04048551326657
UDI-Public4048551326657
Combination Product (y/n)N
PMA/PMN Number
K161554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUI500
Device Catalogue NumberUI500
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-