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

Model Number 011050-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2024

Event Type  malfunction  

Manufacturer Narrative

The reported device is being transit back to manufacturer for evaluation.Once the evaluation is completed, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the materials reported in this case having issue that the ceramic part of the sheath had broken inside the patient's uterus.Procedure prolong more than 60 mins.Nothing happened to the patient.No injury to patient or third party as reported.

Manufacturer Narrative

This report is to correct section d9 to reflect that the product is not returning for evaluation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ELECTRODE, BIPOLAR
• 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: 18768583
• MDR Text Key: 336972003
• Report Number: 9610617-2024-00045
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K221893
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011050-01
• Device Catalogue Number: 011050-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2014
• 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