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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 Type  malfunction  
Event Description
It was reported that the endoflator 50 would not switch to flow mode during the lap hernia repair.The device could be powered on; however, it gave the error message "system failure occurred" once high flow or pediatric mode was selected.The operator could not close the error message after it appeared so the operator had to power down the device.According to report, this was the first time the reported device being used in such case; however, the device had been in use for almost 10 months.The surgeon completed the procedure using a back up unit.There was no patient impact besides delaying the procedure.
 
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 flow sensors and pressure sensor board were defective.New sensors and pressure sensor board were replaced.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 Key17671370
MDR Text Key322518939
Report Number9610617-2023-00227
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/01/2023
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 Manufacturer10/20/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
Patient RaceWhite
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