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

Model Number	NB12STF
Medical Device Problem Codes	Difficult to Insert (1316); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a robotic laparoscopic cholecystectomy procedure, there was a damaged seal on the device.It was suspected that the unit seal was misaligned so it was difficult to put the robotic camera in.To complete the procedure, the trocar was used and the camera finally went through the trocar.The patient is alive and did not suffer any injuries from this event.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the obturator was received inserted into the cannula.Pmv performed functional testing; the device failed an air leak test.All other components functioned properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6654111
• Report Number: 9612501-2017-05651
• Device Sequence Number: 1530641
• Product Code: GCJ
• UDI-Device Identifier: 20884521076492
• UDI-Public: 20884521076492
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2017

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: 07/31/2021
• Device Model Number: NB12STF
• Device Catalogue Number: NB12STF
• Device Lot Number: J6G2459X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 06/26/2017; 06/26/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/20/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1