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

Model Number UNKNOWN VERSASTEP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/30/2020

Event Type  Injury  

Manufacturer Narrative

Title: safety of veress needle for laparoscopic entry in children: myth or reality? source: journal of pediatric surgery, 0022-3468.Https://doi.Org/10.1016/j.Jpedsurg.2020.05.042.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between january 2006 and december 2019 included consecutive patients who underwent laparoscopy in two pediatric hospitals over a 14 year period.A total of 3463 patients younger than 18 years of age underwent laparoscopy procedure.Intraoperative and post operative complications reported includes: 2 patients experienced bowel lesions, 2 failed entry which required conversion to open surgery, 14 patients experienced postoperative issues related to trocar positioning,namely, 9 omental eviscerations through port site insertion and 5 cases of hemoperitoneum owing to epigastric vessels lesion during operative trocar positioning.

Manufacturer Narrative

This event has been reassessed and found to be not a complaint.Additional information.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between (b)(6) 2006 and (b)(6) 2019 included consecutive patients who underwent laparoscopy in two pediatric hospitals over a 14 year period, none of the complications reported were directly related to the use of devices but to the technique used in the study.

• Brand Name: UNKNOWN VERSASTEP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10483738
• MDR Text Key: 205329528
• Report Number: 9612501-2020-01244
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN VERSASTEP
• Device Catalogue Number: UNKNOWN VERSASTEP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR