COVIDIEN LP LLC NORTH HAVEN VERSAONE REUSABLE POSITIONING TROCAR SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
|
Back to Search Results |
|
Model Number RSEAL |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/18/2021 |
Event Type
malfunction
|
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 noted sharp damage on the trocar circular seal.It was reported that there was a damage seal in the device.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue can occur if the device made contact 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: use special care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadvertent damage to the seal.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, following lab evaluation, the seal used with the metal port had a slight tear.There was no damage observed at the beginning of the evaluation when the packaging of the two ports was first opened.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|