MAUDE Adverse Event Report: MEDICAL DEVICES PREMIER PRO; LARYNGOSCOPE

Model Number 6244

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the sampling of inventory tested from the investigation, a disposable handle will break apart before the blade heel would break given the material strength of a blade heel.The product returned showed no signs of damage to the handle however the heel of the blade was broken.It is believed that the cause for the damage is due to end user error as during normal use a device would not break in the same manner as found from the customer returned product.

Event Description

The customer alleges that "blade broke on the acrylic foot." no other details were provided and no patient injury/harm reported.

• Brand Name: PREMIER PRO
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 9480831
• MDR Text Key: 191467026
• Report Number: 1314417-2019-00061
• 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: 12/17/2019

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: 6244
• Device Lot Number: 16Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1