MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. SHORT RUSCH LARYNGOSCOPE HANDLE

Catalog Number ANESTHESIA UNKNOWN

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "incident occurred 23 october 2023.The steel bar used to lock the laryngoscope blade broke when the blade was going to be used.Patient was already under anesthesia.

Manufacturer Narrative

Qn# (b)(4).A sample was not returned for investigation at the manufacturing site.The manufacturer reported: "for this reported complaint, the actual complaint device is not available for returned to determine the actual root cause and the device history record investigation could not be conducted due to unknown lot information.The root cause of this complaint is deemed to be "undetermined /unknown" because there is no actual complaint device returned for physical investigation.In the event if complaint devices will be made available for physical investigation, then this complaint file will be re-open to document the actual findings based on the physical investigation.".Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "incident occurred 23 october 2023.The steel bar used to lock the laryngoscope blade broke when the blade was going to be used.Patient was already under anesthesia.

• Brand Name: SHORT RUSCH LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18211158
• MDR Text Key: 329034714
• Report Number: 8030121-2023-00033
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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 Operator: Health Professional
• Device Catalogue Number: ANESTHESIA UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.