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

Model Number S100712

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Pneumothorax (2012); Impaired Healing (2378); Foreign Body In Patient (2687); Respiratory Insufficiency (4462); Unintended Radiation Exposure (4565)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on laparoscopic video-assisted thoracic surgery (vats) with pleurodesis, a portion of the trocar cannula broke off into the patient and the issue was not discovered until the patient returned with the defective portion of the product still in the body cavity.17 days post-operative of the initial procedure, the patient had a second procedure done in order to retrieve the defective product.Extended hospital stay was required.

Event Description

According to the reporter, the patient had a video-assisted thoracoscopic surgery (vats) with pleurodesis to remove blebs and repair pneumothorax and was discharged.The recovery at home did not process as expected.The patient returned to the emergency room and demanded a computerized tomography (ct) scan which revealed a rectangular artifactual tubular density in the left lung base.It was d iscovered that the 12mm trocar had broken off in the patient's chest cavity and a 1" piece remained after the surgery was completed and the patient was sent home.17 days post-operatively of the initial procedure, there were other fragments that were embedded in the lung tissue that were discovered during the operation in a subsequent ct scan which remained in the patient's lung.The patient experienced numerous symptoms which indicated that there was a post-operative issue remaining.The emergency procedure was performed to remove the piece of trocar and the patient's lung had collapsed and the top portion of the lung was removed.When the trocar piece was discovered, a section of the lower lung was taken out.The surgical time was increased by 30 minutes or more and the incision was extended due to the product problem.There was a chest tube that remained for three days and the patient used a spirometer.The patient stayed in the hospital four days on the second visit.It was noted that the patient had concomitant medical interventions: acetaminophen, ibuprofen, and respiratory inhaler.The patient currently had retained plastic components in the aorta between the heart and lungs, along with another shard on top of the left lobe.The patient will undergo further radiologic imaging, chest x-ray and chest ct scan.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection of the images showed the device in its packaging.Also, additional images showed computer monitor images of the broken cannula during a surgical procedure.It was reported that the obturator was damaged, a component disengaged from the device into the surgical cavity, an extended inpatient stay was required from product failure, an incision of >1 inch was needed resulting from product failure, or time was extended by >30 minutes resulting from product failure, significant surgical intervention was required due to the product failure, and significant tissue loss occurred as a result of the product failure.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

• Brand Name: STEP
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12582539
• MDR Text Key: 274913311
• Report Number: 2647580-2021-03394
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521090672
• UDI-Public: 20884521090672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S100712
• Device Catalogue Number: S100712
• Device Lot Number: P1F1478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White