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

Catalog Number 040-07-0020U

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Cable shorted out and screen froze and light on blade went out while in use.

• Brand Name: PROVU UNIVERSAL REUSABLE 2M AMPLIFIER EXTENSION CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD; no. b-15 xicheng ind zone 1; hengli town; donnguan city, guandong 52346 0; CH 523460
• 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 ; cynon valley business park; mountain ash, rct CF454-ER ; UK CF454ER
• MDR Report Key: 13515454
• MDR Text Key: 287846319
• Report Number: 3006061749-2022-00004
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1