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

Model Number 11278V

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was event with a video-uretero-renoskop.According to the provided information by the customer, the videoscope is not detected by any of their camera system.The leak test passed.No furhter information provided.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.No image or light output due to poor connection between pcb and imager cable.Image and light transmission were restored once the imager cable was secured in place on the pcb.Root cause to loose connection could not be determined.In process & final inspection has verification steps to ensure image & light output is working properly.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE, FLEX-XC
• Type of Device: VIDEO URETERO-RENOSCOPE, FLEX-XC
• 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: 17118509
• MDR Text Key: 317059855
• Report Number: 9610617-2023-00674
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K131369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

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: 11278V
• Device Catalogue Number: 11278V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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