LASER FLEX ENDOTRACHEAL TUBE 43168-145

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for LASER FLEX ENDOTRACHEAL TUBE 43168-145 manufactured by Mallinckrodt Medical, Inc..

Event Text Entries

[2026] The device is an endotracheal tube, especially designed for use in laser surgery. The physician was unable to extubate the patient, an 8 year old girl, at the end of the case. A metal flange on the laser tube was caught on trachael mucosa. The patient was returned to the or following the administration of medication to reduce laryngeal edema and a 4. 5 ett inserted. The patient remined hospitalized overnight and the second ett was sucessfully removed the following day. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: maybe. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3031
• MDR Report Key: 3031
• Date Received: 1992-07-23
• Date of Report: 1991-12-23
• Date of Event: 1991-12-11
• Date Facility Aware: 1991-12-11
• Report Date: 1991-12-23
• Date Reported to Mfgr: 1991-12-11
• Date Added to Maude: 1993-04-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LASER FLEX ENDOTRACHEAL TUBE
• Product Code: LNZ
• Date Received: 1992-07-23
• Catalog Number: 43168-145
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2834
• Manufacturer: MALLINCKRODT MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-23