MAUDE Adverse Event Report: MEDIVATORS ECONOTRAP 2; POLYP COLLECTION BOTTLE

Model Number	100102
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2016
Additional Manufacturer Narrative
This facility reported that they were losing polyp specimens when using the econotrap dual chamber polyp trap during endoscope procedures.There was limited information provided by the facility.Medivators has been in contact with this facility, yet it is unknown how exactly they are using the polyptrap.They have been sent replacements for the reported affected lot and they have not contacted us since.No product has been sent back for additional analysis.The loss of polyp specimens could potentially impact patient treatment in delay of diagnosis.There have been no reported patient illness or injury as a result.This complaint will continue to be monitored within medivators complaint system.
Event or Problem Description
It was reported that this facility was losing polyp specimens during endoscopy procedures.The loss of specimens could potentially impact the patient in delay of patient diagnosis.

• Brand Name: ECONOTRAP 2
• Common Device Name: POLYP COLLECTION BOTTLE
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6122960
• Report Number: 1651395-2016-00006
• Device Sequence Number: 153732
• Product Code: KDQ
• UDI-Device Identifier: 00677964054938
• UDI-Public: 00677964054938
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Replace
• Type of Report: Initial
• Report Date (Section B): 11/22/2016

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: Other Health Care Professional
• Device Model Number: 100102
• Device Lot Number: 819152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1