MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH; LARYNGOSCOPE, RIGID

Model Number	IPN048387
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A middle-aged female with history of elevated blood pressure and svt.Undergoing procedure ankle/foot arthrodesis/fusion and bone graft.Anesthesia assessment identified a loose #9 tooth and warned the patient of risk.During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum.In pacu, the tooth came out.

• Brand Name: RUSCH
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9852939
• Report Number: 9852939
• Device Sequence Number: 3432512
• Product Code: CCW
• UDI-Device Identifier: 14026704663139
• UDI-Public: (01)14026704663139
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/10/2020
• Report Date (Section F): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 1907341
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 98
• Date Report Sent to FDA: 03/10/2020