MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. RICHARD WOLF SEMI RIGID URETEROSCOPE; URETEROSCOPE AND ACCESSORIES FLEX / RIGID

Model Number 8708517

Device Problems Material Separation (1562); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2019

Event Type  malfunction  

Event Description

The 4 french port on the wolf semi ridged scope was occluded by debris, causing the tip of the 0 top basket to shear off in the pt.Foreign body retrieval by dr (b)(6) was successful.Pt was not harmed.We feel device was not properly cleaned and handled down in prep and sterile.Fda safety report id# (b)(4).

• Brand Name: RICHARD WOLF SEMI RIGID URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES FLEX / RIGID
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP. ; vernon hills IL 60061
• MDR Report Key: 8735288
• MDR Text Key: 149514637
• Report Number: MW5087618
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2019

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: Other
• Device Model Number: 8708517
• Device Catalogue Number: 8708.517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 64