MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5; LARYNGOSCOPE, RIGID

Catalog Number 004551035

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint was confirmed, but the root cause is unknown.Upon receipt the blade was visually inspected for any signs of misuse, abuse, or damage.The plastic foot platform and plastic retainer are broken.The complaint has been confirmed.Root cause cannot be established with the current amount of information provided.No corrective/preventative actions will be assigned.No further action required.

Event Description

The customer alleges that the blade had broken plastic pieces.The device was broken when package opened.

• Brand Name: RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5706003
• MDR Text Key: 46784317
• Report Number: 3011137372-2016-00131
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004551035
• Device Lot Number: 1603352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1