MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOLPHIN W/P HANDLE: MINI; LARYNGOSCOPE, RIGID

Model Number IPN915491

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "during a procedure of checking devices, the pediatric nurse checked a laryngoscope handle to make sure it was properly working.She snapped the handle during few seconds on a blade.The light produced was not very bright.She removed the blade and decided to change the batteries of the handle.When she handled the bottom of the laryngoscope handle to unscrew it and remove the batteries, she noticed that this area was burning hot and quickly unhanded the handle.After few minutes it was still hot but no longer burning hot".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).The actual device was returned and sent to the manufacturing site for investigation.The manufacturing site reports "there were no issues identified, with the actual complaint sample.And the complaint device is meeting manufacturing and design /drawing release specification.And found acceptable in functional testing.And the complaint device is performing as intended for use.Therefore, it is concluded that this complaint is not justified".

Event Description

It was reported, "during a procedure of checking devices.The pediatric nurse checked a laryngoscope handle to make sure it was properly working.She snapped the handle, during few seconds on a blade.The light produced was not very bright.She removed the blade and decided to change the batteries of the handle.When she handled the bottom of the laryngoscope handle to unscrew it and remove the batteries, she noticed that this area was burning hot and quickly unhanded the handle.After few minutes, it was still hot, but no longer burning hot".No patient involvement reported.

• Brand Name: RUSCH DOLPHIN W/P HANDLE: MINI
• 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
• MDR Report Key: 12741067
• MDR Text Key: 279695535
• Report Number: 8030121-2021-00036
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711717
• UDI-Public: 14026704711717
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915491
• Device Catalogue Number: 145100
• Device Lot Number: 181201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BLADE; BLADE; BLADE