MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLOSE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Title preliminary results about a novel technique of mesh positioning in the abdominal wall hernia repair source g chir volume 39, 2018 (223-226) article number: 4 date published: july-august 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature study, it showed the results of a different mesh positioning technique in the intraperitoneal onlay mesh mediated abdominal wall hernia repair using dual-mesh prosthesis defined ¿percutaneous technique positioning¿ instead of the classic positioning technique.For all surgical operation, a three-dimensional (3d) textile monofilament polyester (pet) mesh with bioabsorbable collagen film was used.Fixation device was also used.There were 18 postoperative complications which includes wound infection (5), hematoma (5), seroma (7) and recurrence (1).

• Brand Name: ENDO CLOSE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8497965
• Report Number: 2647580-2019-01915
• Device Sequence Number: 19277862
• Product Code: GCJ
• UDI-Device Identifier: 10884521051492
• UDI-Public: 10884521051492
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K954853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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 Model Number: 173022
• Device Catalogue Number: 173022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR