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

Model Number	030450
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic renal transplant, at donor's side, a stapler was used for the resection of renal artery and renal vein.Oozing was noted after the firings.The surgeon stopped the oozing and completed the case with electrosurgical knife but amount of oozing was more than usual.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the loading unit was fully fired.Visual inspection of the sled noted that it was free from damage.Further inspection of the anvil staple pockets noted the proper marks of staples fired.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: 7767465
• Report Number: 1219930-2018-04360
• Device Sequence Number: 1793194
• Product Code: GDW
• UDI-Device Identifier: 10884523002812
• UDI-Public: 10884523002812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• 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,Followup,Followup
• Report Date (Section B): 12/12/2018

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: 08/14/2022
• Device Model Number: 030450
• Device Catalogue Number: 030450
• Device Lot Number: N7H0003X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/22/2018; 11/19/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/14/2018; 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1