MAUDE Adverse Event Report: WELCHALLYN WELCH ALLYN PROXENON LIGHT SOURCE

Model Number N344

Device Problems Component Incompatible (1108); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 09/20/2018

Event Type  Injury  

Event Description

A storz telescope was connected to a welch allyn light source - the metal end on the cable was so hot inside the laryngoscope that it caused burn to pt's lower lip.Possible design flaw that karl storz light cable for scope equipment can universally plus in to welch allyn light source that has an outlet labeled "storz" but is designed for head lamps only.When our team tested the karl storz cable with laryngoscope with the welch allyn light source the metal on the laryngoscope was too hot to touch around 30 mins (light cable inserted inside the laryngoscope).Therapy date: (b)(6) 2018.Diagnosis or reason for use: scope procedure - lysis of anterior laryngeal web.

• Brand Name: WELCH ALLYN PROXENON LIGHT SOURCE
• Type of Device: PROXENON LIGHT SOURCE
• Manufacturer (Section D): WELCHALLYN ; 4619 jordan road; skaneateles falls NY 13152
• MDR Report Key: 8033723
• MDR Text Key: 126092602
• Report Number: 8033723
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N344
• Device Lot Number: UL / IEC 60601-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR
• Patient Weight: 17