MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 3; LARYNGOSCOPE, RIGID

Model Number	IPN048418
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported "miller 3 blade of trulite caused laceration on patients tongue".No serious injury or patient harm reported.No medical intervention reported.Patient condition reported as "fine".
Event or Problem Description
It was reported, "miller 3 blade of trulite caused laceration on patients tongue".No serious injury or patient harm reported.No medical intervention reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed.As it was reported, that the sample is not available for return.Without the device to evaluate, the complaint could not be confirmed.And the probable cause could not be determined, from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 3
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12712488
• Report Number: 8030121-2021-00035
• Device Sequence Number: 4774628
• Product Code: CCW
• UDI-Device Identifier: 14026704626172
• UDI-Public: 14026704626172
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Device Model Number: IPN048418
• Device Catalogue Number: 004670003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown