MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. R WOLFE RING CURETTE; CURETTE, SURGICAL, GENERAL USE

Catalog Number 8435.903

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

During procedure, curette ring broke during use.Fda safety report id# (b)(4).

• Brand Name: R WOLFE RING CURETTE
• Type of Device: CURETTE, SURGICAL, GENERAL USE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; vermon hills IL
• MDR Report Key: 9818211
• MDR Text Key: 183290839
• Report Number: MW5093664
• Device Sequence Number: 1
• Product Code: FZS
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8435.903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 20 YR
• Patient Weight: 68