MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-91

Device Problem Intermittent Energy Output (4025)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned from the customer and no lot number was given, therefore an affected device evaluation could not be completed.In-house inventory were tested from inventory and each handle functioned as intended.No flickering was observed.

Event Description

The customer alleges the "light flickers on handle." no other details were provided and no patient injury/harm reported.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab, pakistan
• MDR Report Key: 8475100
• MDR Text Key: 141103321
• Report Number: 1314417-2019-00013
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2019

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
• Device Operator: No Information
• Device Model Number: 5-0236-91
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Type of Device Usage: N
• Patient Sequence Number: 1