MAUDE Adverse Event Report: GENICON, INC. GENICON GENISURGE; SINGLE-USE MONOPOLAR INSTRUMENT

Model Number	533-005-945
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.
Event or Problem Description
A faulty endoclinch product, 1 533-005-945 opened yesterday in the theatre, which fell apart on insertion into the abdomen, the parts were successfully retrieved and a datix completed.Item was isolated for examination, all other items from that batch were removed from store and are in the theatre controller's office awaiting further advice, it was a lap colorectal procedure, it happened with 2 of the clinches from the same lot, only one returned as the other was contaminated.No staples or clips were in the way at the time, it happened immediately after the instrument was inserted into the abdomen when they opened the jaws.

• Brand Name: GENICON GENISURGE
• Common Device Name: SINGLE-USE MONOPOLAR INSTRUMENT
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10387825
• Report Number: 3002590791-2020-00081
• Device Sequence Number: 16575569
• Product Code: GCJ
• UDI-Device Identifier: 00877972006916
• UDI-Public: (01)00877972006916(10)I60556-B(17)190530
• 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: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Lot Number: I60556-B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1