MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH FOCS ILS MILLER BLADE MIL 00; LARYNGOSCOPE BLADE

Catalog Number 005648000

Device Problems Optical Problem (3001); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

The customer alleges that the light which is normally positioned in the middle of the blade had popped out of its normal location and had swung out laterally, therefore unable to provide adequate light for intubation.The blade was switched out and the patient was successfully intubated without event.

Manufacturer Narrative

(b)(4).The customer also states, in the medwatch, that this is the first problem encountered with the device and the high base has a set screw that may have worked itself loose over time.A visual, functional and dimensional investigation could not be conducted because the device sample was not available for evaluation.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.

• Brand Name: RUSCH FOCS ILS MILLER BLADE MIL 00
• Type of Device: LARYNGOSCOPE BLADE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4713484
• MDR Text Key: 5651363
• Report Number: 1044475-2015-00146
• Device Sequence Number: 1
• Product Code: CCW
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 005648000
• Device Lot Number: 092681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1