MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA; STAPLE, IMPLANTABLE

Model Number	GIA6048L
Medical Device Problem Codes	Failure to Form Staple (2579); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an anastomosis of the duodenum open procedure, they loaded the stapler and when the surgeon tried to close the tissue with stapler, the tissue moved from two halves of stapler.Also loading was not fixed well enough in place where it should be fixed in the stapler.This led to an incomplete staple line and they had to resect and re-staple.Also found the single use stapler was difficult or unable to close on tissue but was ultimately able to close.A stapler of another manufacturer was used to complete the procedure.The patient incurred a duodenum fistula temporary injury.

• Brand Name: GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7100550
• Report Number: 2647580-2017-08578
• Device Sequence Number: 1934233
• Product Code: GDW
• UDI-Device Identifier: 10884521033641
• UDI-Public: 10884521033641
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• 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
• Report Date (Section B): 12/08/2017

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: 03/31/2022
• Device Model Number: GIA6048L
• Device Catalogue Number: GIA6048L
• Device Lot Number: P7C0390X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention