MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-99

Device Problem Intermittent Loss of Power (4016)

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

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the customer supplied e-mail, the devices started to exhibit flickering after sterilization.If the bulb is not properly installed after sterilization it can cause flickering due to a poor connection to the batteries.There is no trending for flickering reusable handles and since the product has not been returned nor have pictures been supplied, this investigation is inconclusive.

Event Description

The customer alleges the "light in handle is flickering." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

At the time of the initial mdr the affected device was not returned.The affected device was returned and were visually inspected and the devices did not show damage or misuse.The handles were returned without batteries so new batteries were installed and the handles illuminated when the led bulb was depressed and when a size 1 and 3 miller blade was installed.The lights remained illuminated with no flickering or turning off when the assemblies were rotated into final use position and pressure was applied to the end of the blade.The customer complaint is not confirmed as the returned products functioned as intended during the investigation.

Event Description

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

Manufacturer Narrative

Based on the customer supplied e-mail, the devices started to exhibit flickering after sterilization.If the bulb is not properly installed after sterilization it can cause flickering due to a poor connection to the batteries.The investigation is inconclusive but there is trending for flickering reusable hangles so a nonconformance will be issued.

Event Description

The customer alleges the "light flickers." 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: 8496378
• MDR Text Key: 141935847
• Report Number: 1314417-2019-00015
• 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,Followup
• Report Date: 05/23/2019

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: 5-0236-99
• Device Lot Number: SB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/24/2019; 05/23/2019
• Patient Sequence Number: 1