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

Model Number	179096PF
Medical Device Problem Codes	Leak/Splash (1354); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy procedure, the first device had air or gas leaked from the seal and the second device had a broken obturator/trocar.They replaced with another device to resolve the issue in order to complete the case.There was no patient injury.

• 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: 6968911
• Report Number: 9612501-2017-06468
• Device Sequence Number: 16411119
• Product Code: GCJ
• UDI-Device Identifier: 20884521081311
• UDI-Public: 20884521081311
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

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 Expiration Date: 05/01/2021
• Device Model Number: 179096PF
• Device Catalogue Number: 179096PF
• Device Lot Number: J6E2427X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1