MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-91

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

The battery was not placed on the spring contact correctly.When the battery was placed into the compartment aligned with the spring, the handle successfully illuminated with the sample blade.Customer complaint of flickering not confirmed.

Event Description

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

Event Description

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

Manufacturer Narrative

The date of report was entered incorrectly on the customer complaint form therefore it was reported incorrectly when the initial mdr was submitted.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab, pakistan
• MDR Report Key: 8214095
• MDR Text Key: 132205168
• Report Number: 1314417-2018-00062
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-0236-91
• Device Lot Number: RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Patient Sequence Number: 1