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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50

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KARL STORZ SE & CO. KG ENDOFLATOR 50 Back to Search Results
Model Number UI500
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  malfunction  
Event Description
It was reported that the endoflator 50 would shut down during partial colectomy surgery.According to the report, the system shut down when the pressure built up to about 6.No heated tubing was used.The surgeon was able to complete the surgery using a back-up unit.There was no report of injury to the patient.
 
Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The reported device was returned and evaluation was performed.The reported complaint was confirmed.Damage was observed with the temperature sensor cap and missing end cover.The system was repaired by replacing heater board, patient connector, 2 flow sensors and temperature sensor cap.The reported issue will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
ENDOFLATOR 50
Type of Device
ENDOFLATOR 50
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM   78532
Manufacturer Contact
anja fair
2151 e grand ave.
el segundo, CA 90245
4242188247
MDR Report Key17761454
MDR Text Key323922916
Report Number9610617-2023-00241
Device Sequence Number1
Product Code FCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUI500
Device Catalogue NumberUI500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2020
Initial Date FDA Received09/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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