MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET

Catalog Number 0055501

Device Problems Failure to Conduct (1114); Optical Problem (3001)

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

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that when the blade is engaged on the handle the light does not always turn on.The device was in the operating room and being prepared for patient use.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and no issues were observed.A rusch emerald fiber optic blade, reusable, was assembled onto the trued handle set.After multiple times of engaging the blade the led in the handle set would not energize.The circumstance of intermittent lighting operation lends itself to an electrical contact issue.After dissecting the battery cartridge and closely examining the small spring loaded contacts connected to the led itself, and the contact pad, the root cause cannot be assigned to a contact issue.The issue relates to a broken or interrupted circuit path, but the interruption could not be detected or recreated during this investigation.The complaint has been confirmed.Manufacturer will continue to monitor and trend related complaints.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be established.

Event Description

The customer alleges that when the blade is engaged on the handle the light does not always turn on.The device was in the operating room and being prepared for patient use.No patient injury reported.

• Brand Name: RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET
• Type of Device: LARYNGOSCOPE HANDLE SET
• 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: 4999704
• MDR Text Key: 22840762
• Report Number: 1044475-2015-00309
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0055501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• 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