MAUDE Adverse Event Report: TELEFLEX MEDICAL JACKSON ANG 4MM CUP FCPS 28CM; JACKSON STR 4MM CUP FCPS 28CM

Catalog Number 505100

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the customer noted that the cup forceps fell apart inside the laryngoscope and that while cupping the instrument it bowed in the middle.

Manufacturer Narrative

Qn#(b)(4).A device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).The device was functionally tested.The jaws were loaded and the handle was actuated to note a small bowing of the shift shaft.This is typical when heavily strained due to the configuration.No functional concerns were noted.I was not able to replicate the reported failure.No functional concerns were noted.The handle can be disassembled for intensive cleaning but is not required.The only plausible explaination for the reported failure is improper assembly after cleaning.

Event Description

It was reported that the customer noted that the cup forceps fell apart inside the laryngoscope and that while cupping the instrument it bowed in the middle.

• Brand Name: JACKSON ANG 4MM CUP FCPS 28CM
• Type of Device: JACKSON STR 4MM CUP FCPS 28CM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8786292
• MDR Text Key: 150878618
• Report Number: 3011137372-2019-00234
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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: 505100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1