MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; STAPLE, IMPLANTABLE

Model Number	EEA2135
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2018
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 a total laparoscopic gastrectomy, while being applied on the esophagojejunal anastomosis, the instrument's handle could be fully squeezed but there was a poor staple formation and bleeding.They had to resect and re-staple the staple line.They used another device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted the wing nut was disengaged.The wing nut was reattached to the instruments and functionally tested with appropriate results.The pushers advanced and knife blade completely and cleanly cut the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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.Replication of the secondary condition can occur if the twist knob is pulled from the instrument by force.No enhancements or improvements were generated for the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7479529
• Report Number: 1219930-2018-02406
• Device Sequence Number: 195967
• Product Code: GDW
• UDI-Device Identifier: 20884523004721
• UDI-Public: 20884523004721
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K062850
• 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): 09/27/2018

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: 02/28/2021
• Device Model Number: EEA2135
• Device Catalogue Number: EEA2135
• Device Lot Number: P6B0591KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention