MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA OMNITRACT; SURGICAL RETRACTORS

Catalog Number XXX-OMNITRACT

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

Patient Problems Numbness (2415); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Based on the absence of lot and catalog information of the products used in this retrospective study review that covers 50 cases from dec 2011 to april 2013, it is not possible to identify the manufacturing time frame to be reviewed and therefore, was not possible to perform the devise history review.Since there was no devices that was returned for evaluation, it is not possible to perform a failure analysis to identify root cause.Doi 10.1002/lt.23940.View this article online at wileyonlinelibrary.Com.

Event Description

Liver transplantation 20:1229-1236, 2014, published on behalf of the american association for the study of liver diseases, original article ¿laparoscopy-assisted hepatectomy versus conventional (open) hepatectomy for living donors: when you know better, you do better¿.The aims for this study was (1) comparing the quality of life of donors undergoing ladh (laparoscopy-assisted donor hepatectomy group) and donors undergoing right lobe hepatectomy via the conventional open technique and (2) assessing any benefits to the donor due to the smaller midline incision during the early postoperative period and 6 months after donation.Methods: fifty donors undergoing right lobe donor hepatectomy between december 2011 and april 2013 were alternately divided into two groups after approval by institutional review committee.Group 1 included 26 donor hepatectomies performed with laparoscopic assistance (the ladh group), and group 2 included 24 donor hepatectomies performed with the conventional open technique [the conventional donor hepatectomy (cdh) group].There were no specific selection criteria for determining the type of donor surgery for any donor.The donors in both groups and their recipients were followed for a minimum period of 6 months.Results: there were no significant differences in the percentages of middle hepatic vein (mhv) grafts and non-mhv grafts between the 2 groups (p50.51), with 19.2% and 29.2% of the ladh and cdh grafts, respectively, being mhv grafts.The 2 groups had similar mean graft weights.The duration of surgery (p50.43) and blood loss (p50.059) were similar in the 2 groups.One donor in each group required an intraoperative blood transfusion (p>0.99).Complications: discomfort related to the scar [including abdominal wall sensorineural deficits (numbness and differences in tactile and temperature sensations) and tightness around the scar], surgical site infections.Conclusions: the use of a laparoscopy-assisted technique in right lobe donor hepatectomy is associated with significantly less postoperative pain and fewer incision-related complications and thus provides better quality of life to the living donor during the early postoperative period.Although the advantage of better quality-of-life scoring became nonsignificant at 6 months of follow-up, donors who had undergone surgery with the laparoscopy-assisted technique still fared better on a subjective evaluation of incision-related parameters.In experienced hands, ladh may provide a way to improve donor comfort and quality of life without compromising donor safety.

• Brand Name: OMNITRACT
• Type of Device: SURGICAL RETRACTORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8061401
• MDR Text Key: 126934142
• Report Number: 3004608878-2018-00257
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-OMNITRACT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1