MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-5852-03

Device Problem Energy Output Problem (1431)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

The returned blade had a bulb installed upon receipt at (b)(4) so the device was installed onto a known functional conventional laryngoscope handle to test the returned devices function.Upon connection to the handle, the bulb on the returned device illuminated.The blade was removed from the handle three (3) times and reinstalled and illuminated each time.This customer complaint is not confirmed since the returned device illuminated.

Event Description

The customer alleges the "blade will not light." 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,
• MDR Report Key: 8616507
• MDR Text Key: 145284989
• Report Number: 1314417-2019-00028
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2019

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: 5-5852-03
• Device Lot Number: RB
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1