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

Catalog Number XXX-OMNIFLEX

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg.Report numbers: 3004608878-2018-00246, 3004608878-2018-00248, and 3004608878-2018-00249.

Event Description

Surgical innovation (2017) published ¿abdominal wall expanding system obviates the need for lateral release in giant incisional hernia and laparostoma¿.In the study, acute intraoperative stretching of the abdominal fascia using a novel abdominal wall expander system (awex) was proposed.The results of abdominal wall reconstruction using this novel system in the first patients were evaluated.Methods: in patients with large incisional hernias and laparostoma where primary midline closure was impossible, awex (abdominal wall expander system) was used.Patient undergoing abdominal wall reconstruction using awex between may 2012 and december 2015 were included.Intraoperative, the abdominal wall was stretched by attaching the midline fascia borders to a retraction system (omni-flex) under tension for 30 minutes.Result: a total of 10 patients underwent abdominal wall reconstruction using awex.For patient #6, procedure was awr (abdominal wall reconstruction) / awex (abdominal wall expander system) cholecystectomy, width gain after fascia stretching using abdominal wall expander system (awex), length gain(cm) = n/a, mesh type used, strattice/ultrapro; mesh size (cm) 30 × 20, mesh position:ipom (intraperitoneal onlay mesh), bridging (cm) = no; morbidity classified according clavien-dindo: relaparotomy for bile leakage, class 3b.Conclusion: stretching of the abdominal wall that has been shown successful using progressive restressed retention sutures and progressive preoperative pneumoperitoneum is reduced from days and weeks to 30 minutes in awex.Awex is a promising alternative to component separation in repair of large incisional hernias.After refinement of the system prospective evaluation is required.

Manufacturer Narrative

Based on the absence of lot and catalog information of the products used in this retrospective study review that covers 197 cases from may 2012 to dec 2015, it is not possible to identify the manufacturing time frame to be reviewed and therefore, was not possible to perform the device 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.There are no indications of manufacturing or design related issues.

Event Description

N/a.

• Brand Name: OMNIFLEX
• Type of Device: SURGICAL RETRACTORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8033984
• MDR Text Key: 125991981
• Report Number: 3004608878-2018-00247
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-OMNIFLEX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STRATTICE; ULTRAPRO; STRATTICE; ULTRAPRO