MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM

Model Number UI500

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Per the evaluation findings: the unit is failing selftest (date error).The battery on the display board is not seated correctly.The battery needs to be reattached.The unit has the new filter board ac.Error code 322 pressure.For the reported issue (shut on and off by itself), this is related to the defective flow/pressure sensors.In this case, it was the pressure sensor which caused the 322 error.

Event Description

It was reported that there was an issue with the product ui500 endoflator 50.Customer reported that the flow on the ui500 turned on/off by itself twice during a case.Customer confirmed they were able to complete the case with another unit, and that there was no injury to the patient.This event is filed under internal complaint id (b)(4).

• 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 ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15639550
• MDR Text Key: 304729609
• Report Number: 9610617-2022-00292
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 05/05/2021
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1