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

Model Number B12STF

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

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 laparoscopic gastroplasty, the membrane of scope retention mechanism broke.Another device was used 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 ; 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: 9530406
• MDR Text Key: 181558384
• Report Number: 9612501-2019-02541
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521539877
• UDI-Public: 10884521539877
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: B12STF
• Device Catalogue Number: B12STF
• Device Lot Number: J8H1337X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Date Device Manufactured: 08/15/2018
• 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