MAUDE Adverse Event Report: GENICON, INC. GENISTRONG; SINGLE USE SPECIMEN RETRIEVAL BAG

Model Number 550-000-005

Device Problems Labelling, Instructions for Use or Training Problem (1318); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.However, through emails and telephone interviews, we discovered there was no harm to the patient (b)(4) as originally recorded in the complaint file.Production records do not record any quality problems during the manufacturing of the device.We also determined the doctor did not use the device as stated in its instructions for use: the doctor attempted to close the specimen retrieval bag while it was still on the biasing arms.The typical sequence of events is to withdraw the metal biasing arms so that the mouth of the bag is no longer being held open by the rigidity of the metal arms.At that point, pulling on the suture may close the bag.Pulling on the suture while the arms are still holding the mought of the bag open results in the arms puncturing the bag, and is a known inherent risk of the device.The user facility indicated that they would be retraining their doctors as to how to use the device appropriately.

Event Description

This report summarizes a previously unreported serious injury event.A complaint was taken over the telephone and documented as "the doctor went to close the bag and the prongs broke through the material and punctured the lungs".

Manufacturer Narrative

Based on interviews with genicon's former representatives who were present during this event, the surgeon did not use the product correctly.The surgeon attempted to close the specimen retrieval bag while it was still on the biasing arms.The sequence of events, as written in the device instructions for use, is to withdraw the metal biasing arms so that the mouth of the bag is no longer being held open by the rigidity of the metal arms and then pull the suture string to close the bag.In this way, the biasing arms are retracted and there is no possibility of the arms puncturing through the bags.

Event Description

This report summarizes a previously unreported serious injury event.A complaint was taken over the telephone and documented as "the doctor went to close the bag and the prongs broke through the material and punctured the lungs".Genincon spoke with former sales representative present during the event and received verbal confirmation there was no patient impact - the product did not puncture the patient's lungs.

• Brand Name: GENISTRONG
• Type of Device: SINGLE USE SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 9803323
• MDR Text Key: 193055350
• Report Number: 3002590791-2020-00003
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K180836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 550-000-005
• Device Lot Number: I9080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other