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	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.Post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo noted a small tear in the circular seal.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.Based on the evidence available the reported condition of seal damaged was confirmed.The root cause of the observed condition was determined to be due to unintended use error.Replication of the cut in the circular seal may occur when mishandled during clinical application.Ifu states: "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, a slight tear was found at the proximal seal of the port.There was no damage observed at the beginning of the evaluation when the packaging of the port 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: 11858085
• Report Number: 1219930-2021-02006
• Device Sequence Number: 3142629
• Product Code: GCJ
• UDI-Device Identifier: 20884521785813
• UDI-Public: 20884521785813
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K201805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1