MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, UNIPOLAR,

Model Number 011110-10

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2023

Event Type  malfunction  

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 during the procedure, the surgery team noticed that the material was not working due to the handle being broken.No negative impact in state of health reported.

Manufacturer Narrative

Result of investigation: as the product has not been sent back, a final determination of the root cause is not possible.Possible reasons for the failure could be: mechanical overload, electrode touching another instrument, resulting in a shortcut and melting the electrode, too high voltage resulting in overheat of the electrode, to long operation without time to cool down, etc.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, UNIPOLAR,
• Type of Device: ELECTRODE
• 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: 19119025
• MDR Text Key: 340959912
• Report Number: 9610617-2024-00108
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011110-10
• Device Catalogue Number: 011110-10
• Device Lot Number: 843661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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