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

Model Number RSEAL

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

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 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11858085
• MDR Text Key: 251923873
• Report Number: 1219930-2021-02006
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521785813
• UDI-Public: 20884521785813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1