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

Model Number	179096PF
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Product analysis #501733389:post market vigilance (pmv) received one versaport v2 fixation cannula 12mm opened by the account without packaging.The visual inspection of the returned product noted that cannula was disengaged from the trocar.The bladed obturator, circular seal and envelope seal appeared intact.The condition in which the device was received precludes functional testing.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.Note: this is a supplemental report for the evaluation.The original report was sent by asr.Asr submitted under us201607-1361 date sent (b)(6) 2016 mdr report number: 9612501-2016-00360.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the base of the trocar is broken; released so that was inserted into the patient.No injury reported.

• 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: 7846636
• Report Number: 9612501-2018-01579
• Device Sequence Number: 1536114
• Product Code: GCJ
• UDI-Device Identifier: 20884521081311
• UDI-Public: 20884521081311
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 179096PF
• Device Catalogue Number: 179096PF
• Device Lot Number: J5F1549X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other