MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH GREEN RUSCHLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Catalog Number 004551004

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

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This investigation of this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges the device was found broken.No patient involvement reported.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.A visual exam was performed and it was observed that the blade was broken.It is unknown where the damage occurred as all products are inspected at the manufacturing facility prior to shipment; therefore, a defect of this type would be detected prior to release.The complaint was confirmed; however, a root cause could not be established.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges the device was found broken.No patient involvement reported.

• Brand Name: RUSCH GREEN RUSCHLITE DISP MTL MAC 4
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6212167
• MDR Text Key: 63479312
• Report Number: 8030121-2016-00040
• 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,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004551004
• Device Lot Number: 1604342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• 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