MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO-URETERO-RENOSCOPE FLEX XC

Model Number	11278VS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was initially reported that the "laser fibre went through during procedure in the theatre.Leak.Faulty angulation".No negative impact in state of health reported.On july 9, 2024 we were informed that the procedure was aborted because of the reported malfunction.Consequently, the surgery was rescheduled.Since the surgery was aborted, the case is deemed as reportable.

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Common Device Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19795229
• Report Number: 2020550-2024-00223
• Device Sequence Number: 17941841
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 4048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/19/2024
• Report Date (Section F): 07/18/2024

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: 11278VS
• Device Catalogue Number: 11278VS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• 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