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

Model Number	179096P
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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 a laparoscopic right colectomy on the traverse colon, the cartridge could not be inserted easily in a trocar as it's supposed to be, and once inserted the device could not be fired.Another device was used to complete the case.There was no patient injury.

• Brand Name: VERSAPORT PLUS
• 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: 8311425
• Report Number: 9612501-2019-00194
• Device Sequence Number: 1929498
• Product Code: GCJ
• UDI-Device Identifier: 20884521081304
• UDI-Public: 20884521081304
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K952977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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 Model Number: 179096P
• Device Catalogue Number: 179096P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1