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

Model Number	179078PF
Medical Device Problem Codes	Detachment Of Device Component (1104); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2017
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 laparoscopic procedure, the gas inlet of the device was cracked/broken.The rubber part which is under the cover is leaving from its place in the case while using 5 mm tool.A new device was used in order to complete the case.No patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, per additional information received during a laparoscopic bariatric procedure, the gas inlet of the device was cracked/broken.The lens disengaged.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device opened by the account with the appropriate packaging in undamaged condition.The visual inspection of the returned product noted that the obturator was received inserted into the cannula.The insufflation port was cracked.The flip top seal was disengaged.The trocar, cannula, circular seal and envelope seal appeared intact.Pmv performed functional testing; the device failed an air leak test.Prolonged insertion of the obturator into the cannula can cause the envelope seal to become stretched.Forwarded to engineering for further investigation of the device and disengaged seal.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: 6816937
• Report Number: 9612501-2017-06011
• Device Sequence Number: 131695
• Product Code: GCJ
• UDI-Device Identifier: 10884521082687
• UDI-Public: 10884521082687
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2017

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: 12/31/2021
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J6M1969X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/14/2017; 11/03/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 09/13/2017; 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1