MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENSPEC FO HANDLE MEDIU; LARYNGOSCOPE, RIGID

Catalog Number 004411100

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

Patient Problems Burn(s) (1757); No Patient Involvement (2645)

Event Date 12/21/2017

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 in progress.

Event Description

Customer complaint alleges "handle malfunction - bulk (bulb) staying on and over heating handle even when blade is not engaged".There was no report of patient involvement.Reporter states user was burned.There was no report of necessary medical intervention.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint alleges "handle malfunction - bulk (bulb) staying on and over heating handle even when blade is not engaged".There was no report of patient involvement.Reporter states user was burned.There was no report of necessary medical intervention.

• Brand Name: RUSCH GREENSPEC FO HANDLE MEDIU
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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: 7164184
• MDR Text Key: 96378533
• Report Number: 8030121-2018-00002
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004411100
• Device Lot Number: 170401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• 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: Initial
• Patient Sequence Number: 1