MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EXTRA VIEW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number OMS-XB2

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: oms-xb2, oms-xb2 extra view balloon oval x5, (lot #p3g0050) oms-xb2, oms-xb2 extra view balloon oval x5, (lot #p3g0050) oms-xb2, oms-xb2 extra view balloon oval x5, (lot #p3g0050) 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 lap total extraperitoneal hernia repair, three trocars all failed for use.One trocar seal came off completely while in use, two trocars leaking around the seal and one of these two failed completely when attempting to insert mesh through same.Had to open new ones continually in order to complete surgery and delayed surgical time.

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the balloon was broken at the distal end.The main valve seal and converter doors appeared intact.The insufflation bulb was received.Functionally, the balloon could not be inflated due to the hole at the distal end.The converter doors move freely and were secured in place.It was reported that one trocar seal came off completely while in use, two trocars leaking around the seal and one of these two failed completely when attempting to insert mesh through same.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact was made with a sharp surgical instrument during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.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.

• Brand Name: EXTRA VIEW
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18755035
• MDR Text Key: 336064144
• Report Number: 2647580-2024-00888
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K954175
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OMS-XB2
• Device Catalogue Number: OMS-XB2
• Device Lot Number: P3G0050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Date Device Manufactured: 07/05/2023
• 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: SEE H10