MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-39

Device Problem Output Problem (3005)

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

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Customer returned one (1) handle and it was from lot pl.Visual inspection of the outside of the handle showed normal wear and use.Nothing stood out at abusive or abnormal but the blue plastic insulator was loose inside the handle.The blue plastic insulator threads were stripped which indicates improper removal and disassembly when compared to the ifu.The led cartridge was also reviewed and showed damage as the lamp body was bent at an angle.A damaged blue plastic insulator and a bent lamp body will both cause the handle to not illuminate and demonstrator improper handling of the device.

Event Description

The customer alleges that "handle not lighting." 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: 8743626
• MDR Text Key: 149791325
• Report Number: 1314417-2019-00038
• 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: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-0236-39
• Device Lot Number: PL, QK
• Type of Device Usage: N
• Patient Sequence Number: 1