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

Model Number	26159BE
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported during a hysteroscopy procedure, the tip of the instrument broke and the broken piece remained inside the endometrium of the patient.The piece was not recovered.
Additional Manufacturer Narrative
The complained 26159be was not received at the manufacturing site for investigation.The investigation has therefore been completed on 2024-11-22 on the basis of the available information.According to the customer's description, it can be assumed that the user is at fault.The tip is said to have flown off, which may have been caused, for example, by excessive force being applied to the sling.On the other hand, the number of reprocessing and applications can have a negative effect on the material properties.The ifu refers to the relevant points.However, as no article was sent in for examination, a more detailed examination cannot be carried out.The device history records have been checked and found to be according to the specicifation, valid at the time of production.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIPOLAR DISSECTION ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20546879
• Report Number: 9610617-2024-00418
• Device Sequence Number: 7873280
• Product Code: GCJ
• UDI-Device Identifier: 04048551094228
• UDI-Public: 04048551094228
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 11/25/2024

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: 26159BE
• Device Catalogue Number: 26159BE
• Device Lot Number: RO01
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown