MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EMERALD FO MACINTOSH BLAD; LARYNGOSCOPE BLADE

Catalog Number 004433300

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

The customer alleges that the fiberoptic light at the distal end of the blade was damaged.The issue was discovered by biomed staff during inspection.

Manufacturer Narrative

(b)(4).Patient identifier - per user facility, device usage when alleged issue was detected is unk.The blade was received with no packaging.A visual inspection was performed on the blade.It was immediately noted that the fiber optic bundle at the distal end of the blade was damaged.It appears as though something forceful moved the bundle backwards into that cavity of the blade that is inaccessible.The complaint has been confirmed.Although the complaint is associated with the damaged fiber optic bundle, the blade was attached to a known good standard rusch handle.The light was transmitting, but the damaged and dislocated distal end of the optic bundle prevented a bright transfer.The complaint has been confirmed.Root cause cannot be established.No corrective/preventative actions assigned.Conclusions: a conclusion code could not be identified.The complaint was confirmed, but the root cause is unk.

• Brand Name: RUSCH EMERALD FO MACINTOSH BLAD
• 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: 4523879
• MDR Text Key: 5495167
• Report Number: 1044475-2015-00056
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 004433300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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