MAUDE Adverse Event Report: NOVO SURGICAL INC. NOVO SURGICAL MCIVOR MOUTH GAG

Model Number 4553-20

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problem Injury (2348)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Novo surgical started its preliminary investigation by obtaining additional information from the user/facility and requesting that the affected products be returned.The returned products were evaluated by novo surgical's quality assurance for their tensile strength to determine if the products met specification.Once the frames were secured properly to the handles, the evaluated devices were able to withstand force in significant excess of what would typically be encountered in surgery.No non-conformities were observed with these devices.Novo surgical identified no corrective actions.It is possible that the frame was not affixed securely to the handle at the time it came apart and/or that the use of an adult frame on a pediatric patient contributed to the injury as significantly more pressure would need to be applied to fit an adult gag into the mouth of a pediatric patient.A device history review uncovered no previous recorded quality problems or complaints associated with this item.

Event Description

Novo surgical inc.Received a sus voluntary event report from the fda (report mw5084100) notifying it of a mdr submitted by a user/facility with regards to a mcivor mouth gag (item no.4553-20) supplied by novo surgical.The fda correspondence dated february 27, 2019 was delivered via postal mail and received by novo surgical on march 6, 2019.This was the first notification to novo surgical of this complaint.This product is comprised of two parts (a frame and handle) that are to be assembled together with two detachable screws when in use.The product may be disassembled during sterilization.In the sus voluntary event report, the user/facility had indicated that the item came apart as it was being positioned in a pediatric patient's mouth and knocked out one of the patient's front top incisors and significantly loosened another.User/facility also reported that one of the screws of the mouth gags was found to be missing and not recovered and that x-ray confirmed that the patient did not swallow the screw.

• Brand Name: NOVO SURGICAL MCIVOR MOUTH GAG
• Type of Device: MCIVOR MOUTH GAG
• Manufacturer (Section D): NOVO SURGICAL INC.; 700 commerce drive; suite 500-118; oak brook IL 60523
• Manufacturer Contact: rupanshi naik ; 700 commerce drive; suite 500-118; oak brook, IL 60523 ; 8778606686
• MDR Report Key: 8480591
• MDR Text Key: 146535117
• Report Number: 3008770252-2019-00001
• Device Sequence Number: 1
• Product Code: KBN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4553-20
• Device Catalogue Number: 4553-20
• Device Lot Number: M4/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 4 YR