MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMED; LARYNGOSCOPE

Model Number 3-01B7-01

Device Problem Defective Component (2292)

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

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned and no lot number has been provided.Customer complaint cannot be confirmed.

Event Description

The customer alleges that "light not working in handle." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

The device was returned with the original box and ifu.The lamp cartridge was not threaded into the head of the handle but was inside the handle.The lamp cartridge was threaded into the head of the handle and new batteries were installed to test for illumination.The bulb illuminated when the lamp cartridge was depressed so a size 3 miller blade was installed.The bulb illuminated when the blade was installed and remained illuminated when the handle was rotated into an end use position and the blade was pressed on simulating use.At no point during these movements did the bulb turn off.Once the blade was removed, the bulb turned off as intended.Therefore, the device functions as intended.

Event Description

The customer alleges that "handle is not working properly." no other details were provided and no patient injury/harm reported.

• Brand Name: EVALUMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 8823275
• MDR Text Key: 152192054
• Report Number: 1314417-2019-00040
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3-01B7-01
• Patient Sequence Number: 1
• Patient Outcome(s): Other