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

Model Number	EEATAID25D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/18/2018
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, during introducing the stapler on a laparoscopic gastric bypass, the anvil tilted after firing and meso has been damage.They close the defect to complete the case.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have 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: 7659052
• Report Number: 1219930-2018-03575
• Device Sequence Number: 2501509
• Product Code: FZX
• UDI-Device Identifier: 20884521045719
• UDI-Public: 20884521045719
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: K7J0003X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR