MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179078PF

Device Problem Packaging Problem (3007)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter during laparoscopic surgical procedure of the abdomen, the trocar sleeve is unsealed at the time of its implantation at the abdomen.To fix the issue, another trocar was used to complete the procedure.There was no patient injury.

• Brand Name: VERSAPORT PLUS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12338766
• MDR Text Key: 267143373
• Report Number: 9612501-2021-01386
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521082684
• UDI-Public: 20884521082684
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J0J2747Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1