MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-90

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

No customer product was available for testing.An inventory evaluation was performed to check for reported defect in house.No samples from evaluation had any issues with flickering.Customer complaint could not be 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

Corrected data: the date of report was entered incorrectly on the customer complaint form therefore it was reported incorrectly when the initial mdr was submitted.Evaluation summary: returned handle penlite (5-0236-90) lot # rd was returned with batteries installed from the customer.When the led light was depressed with a miller size 0 blade the light did flicker.However, when the handle was disassembled it was visually noticed that the led cartridge had been removed with a tool as there was damage to the orange plastic (see attached picture).It was also discovered that the led cartridge assembly was not fully tightened in the assembly so the led cartridge was turned ¼ turn by hand to fully tighten.After the proper installation of the led cartridge was completed, the handle was reassembled and the same customer supplied batteries were used to illuminate the led light.The light no longer flickered.The handle was rotated, shock, and even dropped from a height of 24 inches with the miller size 0 blade installed and the led light stayed illuminated, no flickering.The flickering light was due to the led cartridge not being fully threaded back into position by the customer after sterilization.Returned handle medium (5-0236-99) lot # sg was returned without batteries installed.New batteries were installed and the handle illuminated as expected when a miller size 0 blade was installed.The handle was rotated, shock, and even dropped from a height of 24 inches with the miller size 0 blade installed and the led light stayed illuminated, no flickering.The led cartridge was reviewed when new batteries were installed and it did not exhibit any mis-use and was fully threaded into position.This returned handle functioned as intended and did not exhibit any flickering.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab, pakistan
• MDR Report Key: 8213965
• MDR Text Key: 132203734
• Report Number: 1314417-2018-00061
• 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: 02/01/2019

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: 5-0236-90
• Device Lot Number: RD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2019
• Patient Sequence Number: 1