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

Model Number	EGIATRS45AMT
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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: during pneumothorax, a yellow foreign material fell into the cavity but it was retrieved.The surgeon noticed yellow shipping wedge of the reload was broken.The surgical time was extended by less than 30 minutes.No patient injury.As the surgeon could not identify of which reload the yellow foreign material had belong, the surgeon reported 2 reloads.After the surgery, the sales rep spoke with the customer and confirmed this event caused by a new nurse's device handling.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one shipping wedge for one device.The visual inspection of the shipping wedge of the reload confirmed there were no abnormalities that would have caused or contributed to the reported condition.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7606603
• Report Number: 1219930-2018-03148
• Device Sequence Number: 2129662
• Product Code: GDW
• UDI-Device Identifier: 20884521190884
• UDI-Public: 20884521190884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 06/30/2020
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Device Lot Number: N7F0273KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1