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

Model Number	179094
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
According to reporter during the laparoscopic cholecystectomy, the instrument not close the jaw clips and blocks the same without closing the clip.There was there any unanticipated tissue loss or damage as a result of this problem.There was no blood loss of 500cc or more due to the product problem.Surgical time was not extended by more than 30 minutes due to the product problem.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAPORT
• 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: 6650059
• Report Number: 9612501-2017-05643
• Device Sequence Number: 16465193
• Product Code: GCJ
• UDI-Device Identifier: 20884521081267
• UDI-Public: 20884521081267
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K952977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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 Model Number: 179094
• Device Catalogue Number: 179094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1