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

Model Number IPN048387

Device Problem Break (1069)

Patient Problem Tooth Fracture (2428)

Event Date 03/10/2020

Event Type  malfunction  

Event 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
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9852939
• MDR Text Key: 184081949
• Report Number: 9852939
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704663139
• UDI-Public: (01)14026704663139
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 1907341
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21170 DA
• Patient Weight: 98