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

Model Number	111985
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study compared outcomes of patients who underwent sleeve gastrectomy with gastroileostomy anastomosis using a circular stapled anastomosis or a linear stapled anastomosis between january 2018 and april 2019.In the linear stapled group, a tri-staple stapler may have been used to create the sleeve, ileal transection and anastomosis.In the circular stapled group, a linear stapler was used to create the sleeve and the ileal transection and a circular stapler was used for the anastomosis.A suture was used to close the enterotomies.There were 24 patients in the study and complications included: 2 hemorrhages in the linear stapled group and 1 bleeding in the circular stapled group.No interventions were specified.Complications were not related to the suture.
Additional Manufacturer Narrative
Title: comparative evaluation of efficiency for gastroileostomy anastomosis in laparoscopic transit bipartition with sleeve gastrectomy between linear and circular staplers source: videosurgery miniinv 2022; 17 (1): 199¿206 doi: https://doi.Org/10.5114/wiitm.2021.107756.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
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14436016
• Report Number: 2647580-2022-01700
• Device Sequence Number: 5732952
• Product Code: GDW
• UDI-Device Identifier: 10884523006599
• UDI-Public: 10884523006599
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K001895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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 Model Number: 111985
• Device Catalogue Number: 111985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Unknown