MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111983
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a radical resection of colon procedure, the device jaws were difficult or unable to open.There was poor staple formation and the staple line was incomplete - they oversewed the staple line.Also the donut was not complete.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device.The visual inspection of the returned product noted the safety was broken during functional testing.Additional information : if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis summary: post market vigilance (pmv) received one device.The visual inspection of the returned product noted the safety was broken during functional testing.Forwarded to ponce engineering for further evaluation of broken safety.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PREMIUM PLUS CEEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6869716
• Report Number: 2647580-2017-06634
• Device Sequence Number: 19034598
• Product Code: GDW
• UDI-Device Identifier: 10884523006582
• UDI-Public: 10884523006582
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2018

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: 10/28/2017
• Device Model Number: 111983
• Device Catalogue Number: 111983
• Device Lot Number: P2K0219X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 12/14/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 12/07/2017; 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR