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

Model Number S100710

Device Problems Detachment of Device or Device Component (2907); Packaging Problem (3007)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when pulling out the trocar, it broke in half into the patient.Parts were retrieved.X-ray was taken out to ensure nothing was left in the patient.Another device was used to complete the case.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the cannula was broken in half.The trocar, circular seal appeared intact.The radially expandable sleeve was received.The obturator was not received.The condition in which the device was received precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the damaged and broken trocar may occur the device is handled roughly during a surgical procedure.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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
• MDR Report Key: 9159128
• MDR Text Key: 161349140
• Report Number: 2647580-2019-04972
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521090665
• UDI-Public: 20884521090665
• Combination Product (y/n): N
• PMA/PMN Number: K961940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S100710
• Device Catalogue Number: S100710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention