MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL REUSABLE 2M AMPLIFIER EXTENSION CABLE; LARYNGOSCOPE

Catalog Number 040-07-0020U

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

User could not get airway with provu due to cable failure.

Manufacturer Narrative

The lot/serial number was not given, and the sample was not returned therefore manufcturing date has been inputted as 17oct2022 (the date awareness was given to manufacturer).It was thougt that this event was previously submitted on 11nov2022, however during review, no submission detailsl were seen and therefore submitted at this time.

• Brand Name: PROVU UNIVERSAL REUSABLE 2M AMPLIFIER EXTENSION CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no.b-15 xicheng ind. zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 18920780
• MDR Text Key: 337859874
• Report Number: 3006061749-2022-00017
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0020U
• Device Lot Number: NOT KNOWN
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1