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

Model Number BPT12STS

Device Problems Detachment of Device or Device Component (2907); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

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 a procedure, the trocar broke when placing into patient's abdomen.A second trocar was placed into the patient's abdomen without difficulty.The trocar broke in the same place the first one broke.All parts accounted for and placed in biohazard bag for review.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: 10511943
• MDR Text Key: 206292120
• Report Number: 9612501-2020-01286
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521515703
• UDI-Public: 10884521515703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• 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 Model Number: BPT12STS
• Device Catalogue Number: BPT12STS
• Device Lot Number: J9KD0096DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2020
• 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