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

Model Number	26158BE
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, during the performance of a hysteroscopic procedure, using the bipolar electrode in question to electrocute a naboth cyst, there was a sudden detachment of the active part of the said electrode, which instantly fragmented, making it impossible to recover any fragments in the uterus.
Additional 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).

• Brand Name: BIPOLAR VAPORIZATION ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18023091
• Report Number: 2020550-2023-00330
• Device Sequence Number: 12661091
• Product Code: GCJ
• UDI-Device Identifier: 04048551094204
• UDI-Public: 4048551094204
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2023
• Report Date (Section F): 10/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 26158BE
• Device Catalogue Number: 26158BE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown