MAUDE Adverse Event Report: TELEFLEX MEDICAL TOBEY LARYNGOSCOPE HOLDER; TRAY, SURGICAL, INSTRUMENT

Catalog Number 502248

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on a patient, "the locking mechanism will not stay locked during procedure".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: TOBEY LARYNGOSCOPE HOLDER
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18911735
• MDR Text Key: 337742603
• Report Number: 3011137372-2024-00034
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 14026704721105
• UDI-Public: 14026704721105
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 502248
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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