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

Model Number	179078P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
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 laparoscopic bilateral salpingo-oophorectomy, the device¿s seal was damaged.The white rubber seal was missing on the trocar after they used a large bag to retrieve specimen.They realized a part of the trocar was missing since they kept having air-leaks.They realized the seal was missing.They had to look inside the abdomen of the patient to finally find the seal after 10 minutes.There was no injury caused to the patient and no medical intervention was required.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the cannula, obturator, trocar, envelope and circular seal appeared intact.The white gasket seal for the trocar was disengaged and not received.The flip top converter was not received.Pmv performed functional testing: the knife blade advanced and cut through the test media.The port failed an air leak test.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the disengaged white trocar gasket may occur if the device is mishandled or handled roughly during application.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.

• 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: 7130608
• Report Number: 9612501-2017-06807
• Device Sequence Number: 16506546
• Product Code: GCJ
• UDI-Device Identifier: 20884521082660
• UDI-Public: 20884521082660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K954108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 179078P
• Device Catalogue Number: 179078P
• Device Lot Number: J6L2339X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1