MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM

Model Number 8702524

Device Problem Poor Quality Image (1408)

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

Event Date 12/22/2021

Event Type  malfunction  

• Brand Name: E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM
• Type of Device: URETERORENOSKOP 5° 6/7,5CH NL 430MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13455526
• Report Number: 9611102-2022-00004
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: MO
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8702524
• Device Catalogue Number: 8702.524
• Device Lot Number: 1473065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown