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

Model Number	VS100712P
Medical Device Problem Codes	Difficult to Insert (1316); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic appendectomy procedure, while being applied on the initial entry, the surgeon tried to insert the device into the trocar but it would not go through.It also made a strange noise on all ports.They opened a new trocar to complete the case.No patient injury.
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 obturator, cannula, trocar, envelope seal, circular seal and radially expandable sleeve all appeared intact.The insufflation port appeared intact.Pmv performed functional testing: the device passed an air leak test.The obturator was inserted and removed cleanly from the cannula.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: VERSASTEP 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: 7226528
• Report Number: 9612501-2018-00122
• Device Sequence Number: 984108
• Product Code: GCJ
• UDI-Device Identifier: 20884521082820
• UDI-Public: 20884521082820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012539
• 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
• Report Date (Section B): 03/07/2018

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 Expiration Date: 07/31/2022
• Device Model Number: VS100712P
• Device Catalogue Number: VS100712P
• Device Lot Number: J7G0417X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1