MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE KIT

Catalog Number 005852300

Device Problems Failure to Conduct (1114); Inadequate Lighting (2957)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The customer alleges that the mac 2 blade is flickering and failing.

Manufacturer Narrative

(b)(4).The complaint case sample was rec'd w/some outward damage noticeable to the plastic carrying case.One of the locking latches was missing/broken off the case.Upon opening the kit it was also noted that one of the focs light pipes had been removed from a blade and was laying loose in the case.Also, during visual inspection the handle did not have a battery pack installed, and there were no loose battery packs in the carrying case.Since the laryngoscope handle did not arrive w/ a battery pack installed, a known good kit battery pack (new design) was installed into the handle.Multiple focs blades from the kit were attached to the handle and engaged.All of the blade lights were energized w/no flickering, no interruptions.The complaint cannot be confirmed.No corrective/preventative actions assigned.No further action required.

• Brand Name: RUSCH MRI COND FIBER OPTIC LARYN KIT
• Type of Device: LARYNGOSCOPE KIT
• 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: 4658477
• MDR Text Key: 5599821
• Report Number: 1044475-2015-00141
• Device Sequence Number: 1
• Product Code: OGH
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 005852300
• Device Lot Number: 103301
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Unknown
• Date Manufacturer Received: 03/11/2015
• 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