MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; RIGID ENDOSCOPE WORKING GUIDE

Model Number 27040E

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with a working element.During an intervention, sparking has already occurred repeatedly in the hf application.According to the user, the hf device and hf cable connections were replaced during the procedure and the fault continued to occur.After the initial recording of the fault, the customer thinks that the fault can be localized in the cable connection with the storz resectoscope / monopolar hf loop.

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).

Manufacturer Narrative

This supplemental report is to enter the missing information in section d9.The date in which the product was returned was missing in the initial mdr.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The compliant product was received on 2023-02-24 and was available for investigation.Visual examination revealed that there were traces of use corrosion on the instrument.This indicates possible faulty reprocessing/drying.According to the video sent by the customer, the sparking possibly occurred due to an electrical flashover because of humidity inside the device.Further investigation revealed some melted material on the handle which was probably caused during insertion of the electrode.This may also be due to residual moisture and caused an electrical flashover.In addition, it was found that the cable connection is slightly charred.The product and manufacturing history records have been checked for the inspection lot number and were found to be according to our specifications.A review of the complaint history revealed that no similar incidents have been filed against this product code.On the basis of the available information as well as the investigation results the root cause is most probably reprocessing-related.There is no indication of a material-, manufacturing- or design-related failure.The event is filed under internal karl storz complaint id: the event is filed under internal karl storz complaint id was originally (b)(4) but what changed internally to (b)(4).

• Brand Name: WORKING ELEMENT
• Type of Device: RIGID ENDOSCOPE WORKING GUIDE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16444600
• MDR Text Key: 310353889
• Report Number: 9610617-2023-00047
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551075609
• UDI-Public: 4048551075609
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• 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: 05/16/2023

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 Number: 27040E
• Device Catalogue Number: 27040E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/27/2023; 05/11/2023
• Supplement Dates FDA Received: 03/27/2023; 05/16/2023
• 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