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

Catalog Number	502248
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem 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".
Additional Manufacturer Narrative
(b)(6), n/a, other remarks: n/a, corrected data: n/a.
Event or Problem 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".
Additional Manufacturer Narrative
(b)(4).One sample of 502248 lot w2 was received for evaluation.No visual concerns were noted with the sample.A dimensional inspection was not required as part of this investigation.The device was functionally tested with no concerns noted.The latch closes and engages as expected.This device appears to function correctly and may have been inadvertently captured due to the identical.All complaints are trended across product families on a monthly.Therefore, a separate complaint history review is not required.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 502248.This complaint was not confirmed.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: TOBEY LARYNGOSCOPE HOLDER
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18908102
• Report Number: 3011137372-2024-00035
• Device Sequence Number: 12683210
• Product Code: FSM
• UDI-Device Identifier: 14026704721105
• UDI-Public: 14026704721105
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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
• Operator of Device: 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown