MAUDE Adverse Event Report: SUNMED, LLC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID

Catalog Number 5-5338-12

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2016

Event Type  malfunction  

Event Description

A physician was attempting to use the laryngoscope blade and handle and could not get the light to work.The patient was repositioned several times with no success.

• Brand Name: LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SUNMED, LLC; 2710 northridge dr nw ste a; grand rapids MI 49544
• MDR Report Key: 6036242
• MDR Text Key: 57715971
• Report Number: 6036242
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 5-5338-12
• Device Lot Number: 2015-10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 58