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

Model Number 011050-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

During the procedure (a myomectomy and polypectomy) performed via operative hysteroscopy using bipolar resection, a metallic resection loop broke.The entire medical and paramedical team searched for the tip of this loop without success.The patient was then taken to the scanner to locate this loop.Another device from the same batch was used in an attempt to retrieve the broken loop.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

This correction mdr was initiated to inform the agency that the initial report for this event was submitted in error and was a duplicate of event 20240003744- mdr 24-77.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

This event was submitted as a duplicate of event 20240003744 in error.The final report and information will be provided in case 2024003744 (mdr 24-77).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• 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: 19027807
• MDR Text Key: 339224018
• Report Number: 9610617-2024-00095
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/02/2024

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: 011050-10
• Device Catalogue Number: 011050-10
• Device Lot Number: 848412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• 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