MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN LITE BLADE MAC 3; LARYNGOSCOPE, RIGID

Catalog Number 4343

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

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that components of the device detached/broken.The alleged issue was detected after opening the package.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on the batch number 1603332 and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation.Based on investigations performed on previous complaints with the same issue, this complaint was confirmed.A capa has been opened to further investigate this issue.

Event Description

The customer alleges that components of the device detached/broken.The alleged issue was detected after opening the package.

• Brand Name: RUSCH GREEN LITE BLADE MAC 3
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5823349
• MDR Text Key: 50513697
• Report Number: 3011137372-2016-00233
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 4343
• Device Lot Number: 1603332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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