MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-5273-02

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device in question was manufactured prior to an process improvement where an automatic punching press was implemented to improve placement and seating of the ball bearings and springs.The clean lot for use of this automatic punching press is se (may 2018) and the device in question (lot rl) was manufactured in december 2017.Although, the device was not returned nor were pictures supplied this complaint has been received previously so it is confirmed.A non-conformance will be initiated to finalize the customer complaint since a corrective action has been implemented.

Event Description

The customer alleges the "ball bearings/spring came out of heel of the blade." 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: 8632840
• MDR Text Key: 146287555
• Report Number: 1314417-2019-00031
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-5273-02
• Device Lot Number: RL
• Type of Device Usage: N
• Patient Sequence Number: 1