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

Catalog Number 505104

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).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 505104 and related devices.(1) sample of 505104 was received for evaluation.The device is properly assembled, and no piece are missing.No visual concerns were noted with the device.This device features a shift shaft actuator and a pistol style handle.The distal handle can be disassembled for intensive cleaning but is not required according to the ifu.The only way to "fall apart" is to have the removeable handle improperly seated after cleaning.The device was functionally tested but was unable to reproduce the reported failure.No confirmed complaints were received in this range with the same issue.Similar complaints were received from the same customer for the same issue on related devices.Reference (b)(4) for (b)(4).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) and related devices.A site visit may be warranted for training on the specifics of this device.

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 ANG 4MM CUP FCPS 28CM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8786266
• MDR Text Key: 150980159
• Report Number: 3011137372-2019-00235
• 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: 505104
• 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: 07/25/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1