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

Model Number UI500

Device Problems No Display/Image (1183); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

It was reported that the device stopped working during a procedure and needed to be replaced by a back-up unit.The patient was not harmed but bringing in a re-placement for the device resulted in a delay of the procedure.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.Verified the customer complaint.Unit arrived with the touch screen completely inoperable.Reloaded the software.Engineering change number 3162 requires filter board be replaced with revision ac.Arrived with filter board revision ab.Needs revision ac additional finding not related to the complaint: arrived with software configuration ui500-c02.03 129 total operational hours, source of gas supply "bottle".Resolution: installed a new front panel with touch screen.Pending part delivery.Internal karl storz reference number: (b)(4).

• Brand Name: ENDOFLATOR 50
• Type of Device: ENDOFLATOR
• 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
• MDR Report Key: 18000447
• MDR Text Key: 326454916
• Report Number: 9610617-2023-00328
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UI500
• Device Catalogue Number: UI500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1