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

Model Number 091271-01

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The device is no longer available, and will not be forwarded to the manufacturing site for investigation.Therefore no further evaluation can be conducted.This event is filed under internal complaint id (b)(4).

Event Description

It was reported that during a ureteroscopy on (b)(6) 2024, the rubber sheathing near the distal end of the scope came off and was stuck in the patient.The surgeon had to use a grasper to retrieve the said sheathing.Afterwards, they were able to complete the procedure using a new scope.No patient injury was reported.However this issue caused a delay of about 45 minutes to the case.

• 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 ; 4242188247
• MDR Report Key: 18990028
• MDR Text Key: 339058880
• Report Number: 9610617-2024-00093
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551428016
• UDI-Public: 4048551428016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 091271-01
• Device Catalogue Number: 091271-01
• Device Lot Number: 500088110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1