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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM
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KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM Back to Search Results
Model Number UI500
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Per the customer, their twelve 'endoflator 50' units have failed to keep pressure during several cases, and one case was converted to open procedure (reference mdr (b)(4)).Customer confirmed that all other cases were completed either by using the same unit, or another unit was brought in; they also confirmed there was no negative patient impact in those cases.The total quantity of these cases is unknown and it is also unknown what serial number was involved in any of the cases.Therefore, in addition to mdr (b)(4), we are filing eleven additional reports for each of the customer's other eleven units to represent those cases.This report is the 6th of these additional 11 reports.Customer's 12 'endoflator 50' serial numbers are: (b)(4).
 
Manufacturer Narrative
The device has not been returned for evaluation as of yet.
 
Manufacturer Narrative
The device has not been returned for evaluation as of yet.
 
Event Description
Per the customer, their twelve 'endoflator 50' units have failed to keep pressure during several cases, and one case was converted to open procedure (reference mdr (b)(4)).Customer confirmed that all other cases were completed either by using the same unit, or another unit was brought in; they also confirmed there was no negative patient impact in those cases.The total quantity of these cases is unknown and it is also unknown what serial number was involved in any of the cases.Therefore, in addition to mdr (b)(4), we are filing eleven additional reports for each of the customer's other eleven units to represent those cases.This report is the 6th of these additional 11 reports.Customer's 12 'endoflator 50' serial numbers are: (b)(4).
 
Manufacturer Narrative
Per the evaluation findings for serial number (b)(6) there was no problem found; unit passed all functional tests.
 
Manufacturer Narrative
This report is to correct the serial number that was noted in mdr supplement #1, which also included the evaluation information of 'no problem found' that pertained to the incorrect unit with serial number (b)(6).The correct serial number for this mdr is (b)(6).Mdr supplement #2 does contain the correct evaluation information for serial number (b)(6).
 
Manufacturer Narrative
Per the customer, their endoflator 50 units have failed to keep pressure during several cases.Based on the manufacturer's evaluation, the review of the device history record did not show any non-conformity which could have led to the reported issue.According to the evaluation , the error message 322 could be traced back to a defective pressure sensor.Identical pressure sensors with similar problem were found in the past.Under the microscope torn bond wires (connection from the chip to the outside) could bee.To ensure the reliability of the device, the manufacturer of the pressure sensors was changed.
 
Event Description
Complaint id: (b)(4).
 
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Brand Name
ENDOFLATOR 50, W/INTEGRATED SCB MODULE
Type of Device
LAPAROSCOPIC GAS DISTENSION SYSTEM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM  
Manufacturer Contact
anja fair
13803 n. promenade blvd.
stafford, TX 77477
MDR Report Key13236399
MDR Text Key286258920
Report Number9610617-2022-00008
Device Sequence Number1
Product Code FCX
UDI-Device Identifier04048551326657
UDI-Public4048551326657
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/03/2022
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 Manufacturer01/11/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/13/2021
Initial Date FDA Received01/12/2022
Supplement Dates Manufacturer Received12/13/2021
10/27/2022
10/27/2022
Supplement Dates FDA Received02/09/2022
10/29/2022
11/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
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 Outcome(s) Other;
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