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
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).
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 investigation without product was completed on 2023-11-23.No item was returned to karl storz tuttlingen, therefore no physical inspection of the item in question could be carried out.The customer has provided pictures.Based on these pictures and the failure description, it can be concluded that this damage was caused by overloading the item.The damage may have been caused by too high a force or too long a voltage spike.Internal karl storz reference number: (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
• 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: 18023092
• Report Number: 9610617-2023-00330
• Device Sequence Number: 15352004
• Product Code: GCJ
• UDI-Device Identifier: 04048551094204
• UDI-Public: 4048551094204
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown