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

Catalog Number 5526

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information obtained by teleflex: customer reports the alleged malfunction occurred during use.It was reported there was no injury to the patient.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 handle reaches high temperatures as consequence, the medical doctor can burn." there was no report of a user injury.

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 as per release specification.The sample was not returned for evaluation; therefore the complaint could not be confirmed.

Event Description

Customer complaint alleges "the handle reach's high temperatures as consequence, the medical doctor can burn." there was no report of a user injury.

• Brand Name: RUSCH 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: 7029527
• MDR Text Key: 93005156
• Report Number: 8030121-2017-00155
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• 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: 153201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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