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  

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).

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

As the product was not returned the root cause can't be determined for sure - problem most likely caused by a step in the transition of the luer connector into the working channel.Correction / corrective action: project kw54034 has been started to improve the transition inside the connector to improve the passage of instruments.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Additional information was provided in section h6.The event is filed under internal karl storz complaint id: (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
• 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: 18034411
• MDR Text Key: 326912046
• Report Number: 9610617-2023-00333
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551428009
• UDI-Public: 4048551428009
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K212458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

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
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 01/18/2024
• Supplement Dates FDA Received: 01/18/2024; 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other