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

Model Number	EEATAID25D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/30/2018
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, prior to use, the introducer was spiked on to the stapler and the staff of the introducer broke.The surgeon did not want to use the stapler as the spike was little bent, opened a second stapler.There was no patient involvement.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.Visual inspection noted that the introducer was observed to be broken at grasping notch.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if excessive force is used to insert the end to end anastomosis (eea) instrument with the introducer.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.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: 7646141
• Report Number: 1219930-2018-03477
• Device Sequence Number: 1550611
• Product Code: FZX
• UDI-Device Identifier: 10884521045712
• UDI-Public: 10884521045712
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 09/30/2022
• Device Model Number: EEATAID25D
• Device Catalogue Number: EEATAID25D
• Device Lot Number: K7J0001X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1