MAUDE Adverse Event Report: COVIDIEN VISPRT PLUS 5MM-12MM TRC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	176674P
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, the blade of the gun is not cutting through the tissue.Another visiport was opened and used.There was no patient injury.

• Brand Name: VISPRT PLUS 5MM-12MM TRC
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• MDR Report Key: 5820110
• Report Number: 9612501-2016-00384
• Device Sequence Number: 386979
• Product Code: GCJ
• UDI-Device Identifier: 10884521080652
• UDI-Public: (01)10884521080652(17)201231(10)J5M0708X
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K935086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2016

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: 12/31/2020
• Device Model Number: 176674P
• Device Catalogue Number: 176674P
• Device Lot Number: J5M0708X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2016
• Initial Report FDA Received Date: 07/25/2016
• Patient Sequence Number: 1