MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARNGOSCOPE

Model Number 5-0236-70

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

All suspect product was destroyed by the customer and not returned for evaluation which makes the investigation inconclusive.However, there is trending for disposable laryngoscope handles not illuminating so a nonconformance will be initiated to further the investigation.

Event Description

The customer alleges the "handles failed to light''.No other details were provided and no patient injury/harm reported.

• Brand Name: GREENLINE
• Type of Device: LARNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab, pakistan
• MDR Report Key: 8545021
• MDR Text Key: 143601797
• Report Number: 1314417-2019-00022
• 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: 04/09/2019

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: 5-0236-70
• Device Lot Number: 141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1