MACGYVER MOUTH RETRACTOR/MCIVOR 4553-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for MACGYVER MOUTH RETRACTOR/MCIVOR 4553-20 manufactured by Nova Surgical, Inc..

Event Text Entries

[137057094] Macgyver mouth retractor from novo surgical used for t&a procedure was placed in the mouth of (b)(6) patient. When retractor was being positioned it came apart and knocked out one of the patient? S top front incisors while another incisor was barely hanging. The device has two screws that hold it together. One was not seen after the event occurred. Unable to find on ground or anywhere in operating room. X-ray confirmed pt did not swallow it. Checked remaining 7 macgyver retractors in stock and several of them with both screws would come apart with a slight amount of force. Before checking each one we tightened the screws and still got the result.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5084100
• MDR Report Key: 8343540
• Date Received: 2019-02-14
• Date of Report: 2019-02-12
• Date of Event: 2019-02-07
• Date Added to Maude: 2019-02-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 2

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 3

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 4

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 5

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 6

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 7

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Device Sequence Number: 8

• Brand Name: MACGYVER MOUTH RETRACTOR/MCIVOR
• Generic Name: ACCESSORIES RETRACTOR, DENTAL
• Product Code: EIF
• Date Received: 2019-02-14
• Model Number: 4553-20
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: NOVA SURGICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-14