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

Model Number	EGIAADAPTXL
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
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 laparoscopic gastroplasty procedure, when calibrating the components there was no sign of abnormality.When attempting to trigger the reload broke off and did not fire, the load was disconnected, connected and calibrated again but there was no loading damage.The calibration process was performed again without success.The reload was replaced and the surgery went on.There was no patient injury.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 8275497
• Report Number: 1219930-2019-00504
• Device Sequence Number: 1952810
• Product Code: GDW
• UDI-Device Identifier: 10884521201989
• UDI-Public: 10884521201989
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

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 Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: C2017C731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR