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

Model Number	IPN915491
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8030121-2021-00036
• Device Sequence Number: 1440090
• Product Code: CCW
• UDI-Device Identifier: 14026704711717
• UDI-Public: 14026704711717
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLADE; BLADE; BLADE
• Patient Sex: Unknown