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

Model Number	NONB12SHF
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
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 nephrectomy, about 2 hours passed since the start of surgery, air leak occurred with the seal started suddenly.Because the same events occurred continuously in the last 3 cases, the doctor asked whether the material of the product was changed to be easy to break.Although the device was able to be used without any problem, air leak occurred with the seal continuously.When the collected products were confirmed, a cut portion of about 2 mm in the upper seal was confirmed.The procedure was completed with another device.The surgical time was extended by less than 30 minutes.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: the circular seal was cut.The obturator, trocar, cannula and duckbill seal appeared intact.A functional evaluation found that the device 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.Replication of the cut in the circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 8083932
• Report Number: 9612501-2018-02053
• Device Sequence Number: 1620007
• Product Code: GCJ
• UDI-Device Identifier: 20884521546902
• UDI-Public: 20884521546902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151548
• 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): 03/05/2019

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: NONB12SHF
• Device Catalogue Number: NONB12SHF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1