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

Model Number VS101011P

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

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 oophorectomy and salphingectomy, the cannula and the blunt dilator of the port could not penetrate the mesh.The procedure was completed with another device.There was no patient injury.

• Brand Name: VERSASTEP PLUS
• 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: 10494282
• MDR Text Key: 205925260
• Report Number: 9612501-2020-01257
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521082878
• UDI-Public: 10884521082878
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VS101011P
• Device Catalogue Number: VS101011P
• Device Lot Number: J9L1618Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Date Device Manufactured: 11/17/2019
• 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