MAUDE Adverse Event Report: GENICON GENICON MONOPOLAR; MONOPOLAR MAXI GRIP FENESTRATED GRASPER

Model Number	533-005-945
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Two units of 533-005-945, lot 160556-b, fell apart during a lap colorectal procedure.The parts were successfully retrieved.

• Brand Name: GENICON MONOPOLAR
• Common Device Name: MONOPOLAR MAXI GRIP FENESTRATED GRASPER
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 7578019
• Report Number: 3002590791-2018-00001
• Device Sequence Number: 11078098
• Product Code: GEI
• UDI-Device Identifier: 00877972002192
• UDI-Public: 00877972002192
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/07/2018
• Report Date (Section F): 01/11/2018

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: 05/30/2019
• Device Model Number: 533-005-945
• Device Catalogue Number: 533-05-945
• Device Lot Number: 160556-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1