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

Catalog Number 005852300

Device Problems Inadequate Lighting (2957); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The customer alleges that the light bundle will not light on the mac 2 blade.Intubation was accomplished with a standard laryngoscope set.No patient injury reported.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

(b)(4).The mri kit was returned for evaluation.A visual exam was performed and it was observed that the mac 2 blade was missing.The complaint was reported as the mac 2 blade would not energize when engaged on the handle.The mac 2 blade was not present in the kit; however, during functional testing of all of the returned blades, it was found that two of the blades would not energize: the mac 3, and the mil 1.The small incandescent bulbs which are seated in the focs light bundle were either defective or burned out.Based on the investigation performed, the reported complaint was confirmed.It should be noted that the blade that was reported defective was not returned, but there were defective blades in the kit.The root cause as to why the bulbs burned out could not be determined.A conclusion code could not be found as the complaint was confirmed, however, a root cause was not established.

Event Description

The customer alleges that the light bundle will not light on the mac 2 blade.Intubation was accomplished with a standard laryngoscope set.No patient injury reported.

• Brand Name: RUSCH MRI COND FIBER OPTIC LARYN KIT
• Type of Device: MRI LARYNGOSCOPE KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4883781
• MDR Text Key: 19818290
• Report Number: 1044475-2015-00215
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 005852300
• Device Lot Number: 132601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• 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