MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. ULTRA SAFE HANDLE, MINI; LARYNGOSCOPE, RIGID

Catalog Number 5526

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges the device handle reaches high temperatures.Alleged issue reported as detected during use.No report of patient or user harm or consequence.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges the device handle reaches high temperatures.Alleged issue reported as detected during use.No report of patient or user harm or consequence.

• Brand Name: ULTRA SAFE HANDLE, MINI
• 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: 6687132
• MDR Text Key: 79072574
• Report Number: 8030121-2017-00099
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5526
• Device Lot Number: 131501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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