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
Additional Manufacturer Narrative
(b)(4).
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".
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).The reported complaint 'locking mechanism will not stay locked' was confirmed upon investigation of the returned sample.Visual review of the device noted that the screw which holds the interface surface to the latch was excessively loose.The screw is currently extending past the recessed hole and interferes with the closure of the latch with a scope handle in place.The functional testing revealed interference between the mounting screw of the handle interface interferes with the latch mechanism because it is not properly installed.The screw was removed from the assembly and inspected to find that the mounting screw was cross threaded during reprocessing preventing proper re-assembly of the device.The database was reviewed for complaints pertaining to incoming inspection, stock checks, and product returns and no concerns were noted with the product.Based on these circumstances, it was determined that the user error contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.Udi number unavailable as complainant did not report a lot number.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18911735
• Report Number: 3011137372-2024-00034
• Device Sequence Number: 6759784
• 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: 03/15/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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