MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number 091271-06

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the laser fibre deflected several times unable to proceed - case abandoned.No negative impact in state of health reported.

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).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Type of Device: VIDEO URETERO-RENOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18034459
• MDR Text Key: 326904440
• Report Number: 2020550-2023-00333
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551428009
• UDI-Public: 4048551428009
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 091271-06
• Device Catalogue Number: 091271-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other