MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMED; LARYNGOSCOPE

Model Number 3-01B8-52

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

The returned devices show signs of wear that can only occur from significant use.The reported product codes and device descriptions did not match the physical product received.The returned product is curaplex branded and not evalumed branded product.The medium handle and both blades returned are found as functioning and no signs of defects as stated by the customer complaint.The three stubby handles returned however were found flickering when assembling with a blade.The batteries were tested and had good voltage.Two ot the led cartridges did not show signs of damage however one cartridge had some tool marks from attempting to disassemble the light cartridge but based on the same failure mode with all three handles it is likely that the tool marks do not result in the cause for light flickering.

Event Description

The customer alleges that "light will work during equipment check and will fail at time of intubation." no other details were provided and no patient injury/harm reported.

• Brand Name: EVALUMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 9480636
• MDR Text Key: 191466837
• Report Number: 1314417-2019-00060
• 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: 3-01B8-52
• Device Lot Number: RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1