MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC MULTIFIRE ENDO TA* 30-2.5 DLU; STAPLE, IMPLANTABLE

Model Number	010911L
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a donor nephrectomy procedure, the device was fired on the renal vein.Only part of the staples fired and did not release from the stapler.The stapler was stuck to the vein and the tissue had to be resected in order to remove the device.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• MDR Report Key: 6347377
• Report Number: 2647580-2017-00180
• Device Sequence Number: 37209
• Product Code: GDW
• UDI-Device Identifier: 10884521047761
• UDI-Public: (01)10884521047761(17)200930(10)P5J0532X
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K013860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 010911L
• Device Catalogue Number: 010911L
• Device Lot Number: P5J0532X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STAPLER HANDLE
• Outcome Attributed to Adverse Event: Other