MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE; LARYNGOSCOPE HANDLE, SINGLE USE

Catalog Number 040-310U

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

During intubation the plastic on the handle that holds the metal rod on the larynoscope handle broke and the metal rod fell into patients mouth.The piece was retrived without patient harm.The hospital is unable to provide the lot number of the laryngoscope that broke.

• Brand Name: BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE HANDLE, SINGLE USE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD; no. b-15 xicheng ind zone 1; hengli town; donnguan city, guangdong 52346 0; CH 523460
• MDR Report Key: 12915634
• MDR Text Key: 281596869
• Report Number: 3006061749-2021-00010
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 040-310U
• Device Lot Number: NOT KNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1901
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention