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

Model Number 533-005-945

Device Problem Mechanical Problem (1384)

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

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.

Event 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
• Type of Device: SINGLE-USE MONOPOLAR INSTRUMENT
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint court; suite 114; winter park, fl ; 6574851401
• MDR Report Key: 10387825
• MDR Text Key: 204549564
• Report Number: 3002590791-2020-00081
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972006916
• UDI-Public: (01)00877972006916(10)I60556-B(17)190530
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Initial Date Manufacturer Received: 11/11/2018
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1