MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; GUIDE, SURGICAL, INSTRUMENT

Model Number	EEATAID25D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while setting up prior to a gastric bypass, the scrub discovered that the spike was loose in the anvil.It fell/pulled out easily.The device could not be loaded.A new one was opened to complete the case.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: approved verbiage: post market vigilance (pmv) led an evaluation of one instrument.Visual inspection noted that the introducer center rod was disengaged from the cone head.A review of the device history record indicates this product was released meeting all medtronic quality release specifications.However, a manufacturing fault was identified during product analysis.The root cause was identified as a welding issue.Improvements were initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8499292
• Report Number: 1219930-2019-02176
• Device Sequence Number: 1928416
• Product Code: FZX
• UDI-Device Identifier: 10884521045712
• UDI-Public: 10884521045712
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: EEATAID25D
• Device Catalogue Number: EEATAID25D
• Device Lot Number: K7K0005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 09/20/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 09/04/2019; 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1