MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP WOF RESECTOSCOPE SHEATH SIZE 24

Catalog Number 86553841

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2014

Event Type  Other  

Event Description

Pt underwent a greenlight laser xps, ablation of prostate (manufacturer ams) in conjunction with using a resectoscope sheath manufactured by wolf.Towards the end of procedure the tip of the sheath shattered off into the pt.The tip of the sheath is made of ceramic.All particles were retrieved from pt.No injury to pt.Manufacture notified.

• Brand Name: WOF RESECTOSCOPE SHEATH SIZE 24
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 3851396
• MDR Text Key: 20718319
• Report Number: MW5036456
• Device Sequence Number: 1
• Product Code: FDC
• 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: 05/29/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 86553841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR