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

Model Number	179078PF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	01/09/2018
Type of Reportable Event	Death
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 piercing process in a laparoscopic sleeve gastrectomy, the surgeon inserted the device into the flank and pricked the inferior vena cava, which caused bleeding and ultimately death.Blood loss was greater than 500 cc and blood transfusion was required.The patient died.The surgeon reported there was no issue with the device and the death was caused by his fault for puncturing the vena cava.

• 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: 7352264
• Report Number: 9612501-2018-00553
• Device Sequence Number: 37479
• Product Code: GCJ
• UDI-Device Identifier: 10884521082687
• UDI-Public: 10884521082687
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J7A1644X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death