MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN VERSAPORT TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN VERSAPORT TROCAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Title: short-term outcomes of single-port versus conventional laparoscopic sleeve gastrectomy: a propensity score matched analysis source: surgical endoscopy (2020) 34:3978¿3985 published online: 8 october 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (january 2015 to december 2016) this study aimed to assess the outcome of a short-term outcomes of single-port versus conventional laparoscopic sleeve gastrectomy.With regards to morbidity, weight loss, and co-morbidity resolution.From each of these surgical categories, 314 patients were successfully matched which created the ¿matched cohort¿ group.Total matched cohort postoperative outcomes for the spsg category includes: 90 day postoperative complications (27) ; bleeding intra-abdominal or intraluminal 8); dindo-clavien grade > iiia (14) incisional hernia (5).The ¿dindo-clavien > iiia complications¿ included 13 patients; one patient that presented a post-operative hematoma treated by percutaneous drainage under local anesthesia (iiia).Total matched cohort postoperative outcomes for the clsg category includes: 90 day postoperative complications (21) ; bleeding intra-abdominal or intraluminal (8); dindo-clavien grade > iiia (7); incisional hernia (1).The ¿dindo-clavien > iiia complications¿ included 7 patients: two patients that presented a postoperative hematoma treated by percutaneous drainage under local anesthesia (iiia).Short-term outcomes of single-port versus conventional laparoscopic sleeve gastrectomy: a propensity score matched analysis | hadrien tranchart1,2 · lionel rebibo3,4 · martin gaillard1,2 · abdennaceur dhahri3,4 · panagiotis lainas1,2 ·jean-marc regimbeau3,4 · ibrahim dagher1,2 | department of minimally invasive digestive surgery, antoine béclère hospital, ap-hp, 157 rue de la porte de trivaux, 92140 clamart, france | received: 1 march 2019 / accepted: 26 september 2019 / published online: 8 october 2019.

• Brand Name: UNKNOWN VERSAPORT TROCAR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10676581
• MDR Text Key: 211292566
• Report Number: 9612501-2020-01462
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN VERSAPORT TROCAR
• Device Catalogue Number: UNKNOWN VERSAPORT TROCAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR