MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GRASP; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	174233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: does reduced-port laparoscopic surgery for medically uncontrolled ulcerative colitis do more harm than good? source: asian j endosc surg 91 (2016) 24¿31 © 2015 24 japan society for endoscopic surgery, asia endosurgery task force and john wiley & sons australia, ltd.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of the study, performed between may 2011 and september 2014, 10 ulcerative colitis (uc) patients underwent single-incision plus one port laparoscopic surgery (sils + 1).All procedures were performed using a 5-mm standard definition flexible scope, ultrasonic-activated scissors, activating laparoscopic coagulating shears, and straight and curved graspers.The end of the ileum was cut with the reported stapler, and the ascending colon was mobilized to the hepatic flexure with a retroperitoneal approach.Transanal mucosectomy was performed above the dentate line, and the circumferential muscular layer of the rectum was transected with a stapling device or two firings of a linear cutting roticulating stapler.Post-operatively, one patient had methicillin-resistant staphylococcus aureus (mrsa) enteritis which resolved with conservative management.Does reduced-port laparoscopic surgery for medically uncontrolled ulcerative colitis do more harm than good? 2016 shigenori homma, futoshi kawamata, susumu shibasaki, hideki kawamura, norihiko takahashi & akinobu taketomi.

• Brand Name: ENDO GRASP
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10269904
• Report Number: 2647580-2020-02133
• Device Sequence Number: 804126
• Product Code: GET
• UDI-Device Identifier: 10884523000818
• UDI-Public: 10884523000818
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,user facil
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 174233
• Device Catalogue Number: 174233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/14/2020
• 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
• Patient Age: 32 YR