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

Model Number OMS-T10BTNL

Device Problems Decrease in Pressure (1490); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic hysterotomy, the valve seal disengaged and the balloon leaked gas or air.There was rapid loss of abdominal pressure due to the device issue.Another device was used to resolve the issue.There was no patient injury.

Manufacturer Narrative

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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the flapper door button was broken and the flapper door was inside the body of the device.The trocar balloon, lock collar, main valve seal and converter doors appeared intact.The inflation syringe was not received.The obturator was received.Functionally, the lock collar moved up and down the cannula and securely locked in place.The converter doors moved properly and were fixed securely in place.The balloon was inflated using a test syringe and no leaks were detected.It was reported that the seal disengaged, the balloon leak and there was rapid loss of pneumoperitoneum.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of broken flapper door.The product analysis noted evidence that the device was not used as intended.The issue can occur if excessive force was applied 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: damage to the balloon by instruments used during insertion and in the course of a procedure may cause device failure.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: AUTO SUTURE
• 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: 18664666
• MDR Text Key: 334885486
• Report Number: 2647580-2024-00696
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521527386
• UDI-Public: 10884521527386
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K924011
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OMS-T10BTNL
• Device Catalogue Number: OMS-T10BTNL
• Device Lot Number: P3K1064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 85 KG