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

Model Number	ONB5LGF
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during insertion of trocar in a robotic sleeve gastrectomy, the obturator of the device separated from the upper hub when inserting the trocar.The surgeon used another trocar to resolve the issue.No patient injury.

• Brand Name: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10835729
• Report Number: 9612501-2020-01709
• Device Sequence Number: 3024696
• Product Code: GCJ
• UDI-Device Identifier: 10884521134218
• UDI-Public: 10884521134218
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K112349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2018
• Device Model Number: ONB5LGF
• Device Catalogue Number: ONB5LGF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 119