MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERSAONE REUSABLE POSITIONING TROCAR SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	RSEAL
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: VERSAONE REUSABLE POSITIONING TROCAR SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12164285
• Report Number: 1219930-2021-02811
• Device Sequence Number: 3820585
• Product Code: GCJ
• UDI-Device Identifier: 20884521785813
• UDI-Public: 20884521785813
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: RSEAL
• Device Catalogue Number: RSEAL
• Device Lot Number: N0L0167UY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1