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

Model Number	179103P
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/22/2018
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, prior the procedure, upon opening package, a nurse tried to insert obturator into cannula, but there was resistance.Stopped using and opened another.No patient involvement.

• 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: 7407227
• Report Number: 9612501-2018-00706
• Device Sequence Number: 11043139
• Product Code: GCJ
• UDI-Device Identifier: 10884521081376
• UDI-Public: 10884521081376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 05/31/2022
• Device Model Number: 179103P
• Device Catalogue Number: 179103P
• Device Lot Number: J7E0996X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1