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

Model Number VS101005

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, all 3 trocars were sticking.Whenever a 5mm device was inserted in the trocar it would be difficult to insert or remove the device.

• Brand Name: VERSASTEP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10511975
• MDR Text Key: 206292475
• Report Number: 9612501-2020-01287
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521082837
• UDI-Public: 20884521082837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: VS101005
• Device Catalogue Number: VS101005
• Device Lot Number: J8E2124X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2020
• Date Device Manufactured: 05/23/2018
• 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