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

Model Number NONB12LGF

Device Problems Leak/Splash (1354); Packaging Problem (3007)

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

Event Date 01/22/2021

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 a right inguinal hernia procedure, when the surgeon inserted the laparoscopic instruments, the two trocars' membranes broke and leaked.Another device was used to resolve the issue in order to complete the case.There was no patient injury.

• Brand Name: VERSAONE
• 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: 11869626
• MDR Text Key: 252154656
• Report Number: 9612501-2021-00799
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521546912
• UDI-Public: 10884521546912
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K151548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NONB12LGF
• Device Catalogue Number: NONB12LGF
• Device Lot Number: J0B2027Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Date Device Manufactured: 02/20/2020
• 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