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

Model Number UI500

Device Problems Gas Output Problem (1266); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there was an "error 3fd: poweron test error.Laparotomy instead of laparoscopy." since the description indicates that a laparotomy had to be performed instead of a laparoscopy, this event has been evaluated as reportable.

Manufacturer Narrative

The item in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id:(b)(4).

Manufacturer Narrative

During the investigation of the returned device the power on error 3fd could be confirmed.The deeper investigation has shown that the error occurred due to a too high leakage at the proportional valve during the poweron test.The error was measurable and visible in the log-file.During the test by the verification engineer the fault was resolved by replacing it with a new one or by disassembling and reassembling the original proportional valve.It is concluded that the proportional valve broke due to a component fault.This fault was recognized by the device through the self-test which is performed during power-up when it is supplied with gas.The device should have been switched on and checked for functionality before use in the operation.The following information is stated in the corresponding instructions for use of the device: "check the product for the following properties, for example, before and after every use: functionality, damage, changes to the surface, in the case of several components: completeness and correct assembly.Do not continue to use damages products." "self-test during power-up, the prouct performs a self-test when it is supplied with gas.If the self-test is negative, a corresponding error message is displayed and the product cannot be used properly." the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOFLATOR 50
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• 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: 18466539
• MDR Text Key: 332377801
• Report Number: 9610617-2024-00004
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 05/07/2024
• Supplement Dates FDA Received: 03/08/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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
• Patient Outcome(s): Other