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

Model Number	B11STS
Medical Device Problem Codes	Gas/Air Leak (2946); Packaging Problem (3007)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic appendectomy procedure, the seal was damaged and when a 5mm instrument is inserted into the 11mm port, the seal was not adjusting and co2 gas would leak and pneumoperitoneum was being lost.A 5mm trocar was used to replace the 11mm.The surgery was extended by 30 minutes, but there was no reported patient 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: 8077329
• Report Number: 9612501-2018-02035
• Device Sequence Number: 1527398
• Product Code: GCJ
• UDI-Device Identifier: 10884521539860
• UDI-Public: 10884521539860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 02/28/2023
• Device Model Number: B11STS
• Device Catalogue Number: B11STS
• Device Lot Number: J8B1296X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1