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

Model Number ONB12STF

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

D10: concomitant product: onb12stf, onb12stf versaone opt 12 std trocar (onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar; onb12stf, onb12stf versaone opt 12 std trocar.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 the reporter, during a laparoscopic gastric bypass, when the instruments are used to enter through trocars, all 10 devices had their seal damaged and disengaged.There was also air or gas leaked from the seal of all devices.Another device was used to resolve the issue.There was no patient injury.

Manufacturer Narrative

Information received shows that this event is a duplicate of another issue reported under regulatory report (b)(4).This file will be closed and all further updates processed under the above-referenced report for this event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during a laparoscopic gastric bypass, when the instruments are used to enter through the trocar, their seal were damaged and disengaged for both device.There was also air or gas leaked from the seal for both device.Another device was used to resolve the issue.There was no patient injury.

• Brand Name: VERSAONE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18829561
• MDR Text Key: 337107916
• Report Number: 9612501-2024-00643
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521657687
• UDI-Public: 10884521657687
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K130435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONB12STF
• Device Catalogue Number: ONB12STF
• Device Lot Number: J3G1274Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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
• Treatment: PLEASE SEE NOTE ON H11