MAUDE Adverse Event Report: NOVO SURGICAL, INC. NOVOSURGICAL KOCHER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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

Patient Problem Tooth Fracture (2428)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Broken kochers x2, tooth broken on each one, novosurgical kocher g92723-31.Fda safety report id# (b)(4).

• Brand Name: NOVOSURGICAL KOCHER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): NOVO SURGICAL, INC.
• MDR Report Key: 11862384
• MDR Text Key: 252298336
• Report Number: MW5101480
• Device Sequence Number: 1
• Product Code: GCJ
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR