MAUDE Adverse Event Report: NOVO SURGICAL INC. NOVOSURGICAL KOCHER; FORCEPS

Model Number G92723-31

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 05/19/2021

Event Type  Injury  

Event Description

Broken tooth and ridge of kocher, novosurgical, (b)(4).Fda safety report id# (b)(4).

• Brand Name: NOVOSURGICAL KOCHER
• Type of Device: FORCEPS
• Manufacturer (Section D): NOVO SURGICAL INC.
• MDR Report Key: 11862358
• MDR Text Key: 252154835
• Report Number: MW5101478
• Device Sequence Number: 1
• Product Code: GEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G92723-31
• Device Catalogue Number: G92723-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• 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: 69 YR