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

Model Number	179096PF
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
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, prior the procedure, one device had a disengaged seal.The second stapling device lever could not be squeezed, and staples partially deployed but got stuck in the end of the stapler.This issue was noticed prior to use and there was no patient involved in this event.No additional information was provided.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.The visual inspection of the returned product noted; that the device was received with the obturator inserted into the trocar, prolonged insertion can over stretch the envelope seal.The obturator, trocar, cannula insufflation port and envelope seal appeared intact.Pmv performed functional testing: the device failed an air leak test.The obturator was inserted into the trocar; the device was actuated and fired through the test media.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.

• 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: 6719742
• Report Number: 9612501-2017-05790
• Device Sequence Number: 19082346
• Product Code: GCJ
• UDI-Device Identifier: 10884521081314
• UDI-Public: 10884521081314
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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: 08/31/2021
• Device Model Number: 179096PF
• Device Catalogue Number: 179096PF
• Device Lot Number: J6H1751X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1