MAUDE Adverse Event Report: COVIDIEN VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number 179078P

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

Procedure: sleeve gastrectomy.According to the reporter: small seal on the device was dislodged and fell onto the floor during the case.

Manufacturer Narrative

(b)(4).

• Brand Name: VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4356269
• MDR Text Key: 5199895
• Report Number: 9612501-2014-00473
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

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
• Device Operator: Health Professional
• Device Model Number: 179078P
• Device Catalogue Number: 179078P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1