MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP RICHARD WOLF PEDIATRIC RIGHT ANGLE SCOPE; CYSTOURETHROSCOPE

Model Number 8626.431

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2020

Event Type  Injury  

Event Description

During the cystoscopy, it was noted that the open ended 5 -french ureteral catheter was being sheared by the scope when the catheter was being withdrawn.Two small shavings were in the bladder as a result of this.The fragments from the 5-french ureteral catheter were identified and removed in their entirety.Fda safety report id# (b)(4).

• Brand Name: RICHARD WOLF PEDIATRIC RIGHT ANGLE SCOPE
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP
• MDR Report Key: 9934164
• MDR Text Key: 187045298
• Report Number: MW5094069
• Device Sequence Number: 1
• Product Code: FBO
• 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: 04/06/2020

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: 8626.431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2020
• 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 Outcome(s): Required Intervention
• Patient Weight: 19