MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-69

Device Problem Inadequate Lighting (2957)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

The customer did not return affected device, no evaluation was performed on the device.The end user was able to retain the packaging which, did have the lots numbers for the affected devices.Based on trending and returned devices from same lots, there will be a nonconformance issued for trending.Although there have been affected devices returned and confirmed from same lot, this complaint can not be fully confirmed or disputed without devices returned.

Event Description

The customer alleges that " laryngoscope did 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, pakistan
• MDR Report Key: 7451744
• MDR Text Key: 106392681
• Report Number: 1036445-2018-00020
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-0236-69
• Device Lot Number: 123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 46