MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA PREMIUM; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number	030735L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Code Available (3191)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
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 an open left-sided hemicolectomy procedure, while doing the side-to-side anastomosis, the knife did not cut the tissue between the rows of staples on one side only.It closed one side with densely 4 rows of staples and the other left open.Time of surgery extended over 30 minutes with loss of additional tissue due to defect and manual anastomosis was done.The event also lead to extended hospitalization of 8 days.

• Brand Name: GIA PREMIUM
• Common Device Name: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7582591
• Report Number: 2647580-2018-02771
• Device Sequence Number: 13968931
• Product Code: FHM
• UDI-Device Identifier: 20884521031637
• UDI-Public: 20884521031637
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K801590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 10/31/2022
• Device Model Number: 030735L
• Device Catalogue Number: 030735L
• Device Lot Number: P7K1548X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: Hospitalization; Required Intervention