MAUDE Adverse Event Report: GENICON EZEE SPECIMEN RETRIEVAL

Model Number	550-000-000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a lap chole, the ezee bag was used to remove the gall bladder.When using the scope to remove the trocars at the end of the procedure, the doctor noticed that a piece of the bag (the bead) had fallen into the patient.They were able to retrieve the bead from the patient.Nothing was left behind.

• Brand Name: EZEE SPECIMEN RETRIEVAL
• Common Device Name: SPECIMEN RETRIEVAL
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 7625051
• Report Number: 3002590791-2018-00002
• Device Sequence Number: 16187548
• Product Code: GCJ
• UDI-Device Identifier: 00877972005223
• UDI-Public: 00877972005223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 08/29/2020
• Device Model Number: 550-000-000
• Device Catalogue Number: 550-000-000
• Device Lot Number: I8920
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1