MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. 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 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that the plastic parts on the blade are broken within the package.

Manufacturer Narrative

(b)(4).Lot# has been corrected to 1604332.A device history record (dhr) review was performed on the batch number 1604332 and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.Based on the investigation performed, the complaint was confirmed.A capa has been opened to further investigate this issue.

Event Description

The customer alleges that the plastic parts on the blade are broken within the package.

• Brand Name: RUSCH GREEN LITE BLADE MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TRUPHATEK INTERNATIONAL LTD.; netanya
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6010607
• MDR Text Key: 56796137
• Report Number: 8030121-2016-00003
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 4343
• Device Lot Number: 1604332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• 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