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

Model Number	NONB12LGF
Medical Device Problem Codes	Detachment Of Device Component (1104); Leak/Splash (1354); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a appendectomy, there was a damaged seal and there was air or gas leaking from the seal.The inner membrane of the access port broke off and fell into the abdomen of the patient during the procedure.The surgical time was extended 30 minutes or more due to the product problem.The membrane was removed and the abdominal cavity was cleaned with normal saline.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of five devices.The event report alleges the products were used in a surgical procedure.The visual inspection of the returned products noted that the circular seal from one of the devices was disengaged.The obturator, cannula and envelope seal appeared intact.The other four devices were received sealed in their packaging.Pmv performed functional testing; all the devices passed an air leak test.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.Replication of the disengaged circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAONE
• 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: 6570487
• Report Number: 9612501-2017-05504
• Device Sequence Number: 16392533
• Product Code: GCJ
• UDI-Device Identifier: 10884521546912
• UDI-Public: 10884521546912
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K151548
• 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): 06/23/2017

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 Model Number: NONB12LGF
• Device Catalogue Number: NONB12LGF
• Device Lot Number: J6B2298X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/23/2017; 06/23/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 07/23/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1