MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-5382-09

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device in question was not returned by the customer nor were pictures supplied or a specific lot number for the device in question.Therefore, inventory of a different lot was reviewed at sunmed and the product was found to function as intended.Without the product being returned for evaluation or even a picture it's difficult to determine what might have caused the device to fall apart let alone the root cause of the failure.The investigation is inconclusive regarding this specific device and there no trending of this complaint to further the investigation.

Event Description

The customer alleges the " blade fell apart during use and fell off the handle." 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: 8429220
• MDR Text Key: 139190213
• Report Number: 1314417-2019-00009
• Device Sequence Number: 0
• Product Code: CCW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-5382-09
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1