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

Model Number	B5STS
Medical Device Problem Codes	Difficult to Remove (1528); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
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: occurred during a laparoscopic hysterectomy.The vessel sealing device caused the insufflation machine to alarm due to lack of flow through the trocar.The seal of the port was damaged.The trocar became stuck on the suction irrigator and when they were pulled apart, the internal seal of the trocar broke.To correct the issue, the surgical team had to switch the gas tube from one trocar to another each time the vessel sealing device was passed between them.A second trocar was used when the suction irrigator was stuck inside the trocar.No patient injury or extension in surgical time.Patient status is alive, no injury.

• 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: 6831881
• Report Number: 9612501-2017-06051
• Device Sequence Number: 16535755
• Product Code: GCJ
• UDI-Device Identifier: 20884521539843
• UDI-Public: 20884521539843
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: 01/31/2022
• Device Model Number: B5STS
• Device Catalogue Number: B5STS
• Device Lot Number: J7A0014X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1