MAUDE Adverse Event Report: GENICON MEDIUM GENISTRONG SPECIMEN RETRIEVAL BAG

Model Number 550-000-003

Device Problem Human-Device Interface Problem (2949)

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

Event Date 06/29/2019

Event Type  malfunction  

Manufacturer Narrative

Genicon has completed a thorough review of all available records related to this device and lot number.Records indicate that this lot passed all manufacturing and quality control inspections, with no irregularities or abnormalities noted.Review of the trending history indicates this is the only known occurrence of this failure to date.The suspect devices was able to be retained and shipped to genicon for evaluation.A thorough evaluation of the returned device was completed by engineering, indicting the device was retuned with one of the biasing arms exposed through the lateral pin hole on the mouth of the bag.The device was able to be retracted and deployed without any other issues, and no other non-conformities were noted.Engineering attempted to replicate the malfunction, and given the available information, it is believed this issue was the result of user error.The user prematurely detached the tether and retracted the pull loop.Upon re-deployment the arm was exposed through the lateral pin hole, which is consistent with the narrative and returned device.Care should be taken to follow all warnings, precautions and directions detailed in the instructions for use to ensure the highest level of safety and patient care.The ifu detail the proper steps to follow if trying to re-deploy the bag or capture multiple specimens.Although this event did not result in patient harm, it does have a potential to lead to an adverse event due to the metal arm being exposed within the operating field.Therefore out of an abundance of caution, genicon is notifying the appropriate regulatory authorities.Genicon will continue to monitor this issue through our vigilance system for trends and take appropriate actions as necessary to ensure the continued performance and safety of the product.

Event Description

Reference customer document number per (b)(4): "during the procedure the metal ring at the top of the bag pulled out of the channel preventing it from being able to deploy a 2nd time.The surgeon waited for another bag to be retrieved and opened and refuses to use the bag again.I have the failed bag in a biohazard bag and in my office along with the outside wrapper.We will not be moving forward with the pmi specimen retrievable bag.We do appreciate your efforts in providing the case support over the past 3 weeks." 2nd email on 7/2/2019: "whether it was user error or not - the product failed and with the metal out of the bag channel - redeployment was impossible and another product was retrieved and used without user error.A picture was not taken during this unplanned emergency case.I have the product in my office.Upon my inspection of the bag, it appears that only 1 of the metal arms was sticking out through the tiny "manufactured hole" in the bag material [at the mouth of the bag, above the thread].The other metal arm is properly encased within the channel of the bag material." additional information (handwritten note) included with the retuned device: "dr.Amr was upset i opened this bag said to get him the applied bag.I told him there were none on the shelf so he went ahead and tried to use it but this it ripped while deploying.He told tosha to go find another bag.She was unable to find any so he had to use another one of these".

• Brand Name: MEDIUM GENISTRONG SPECIMEN RETRIEVAL BAG
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer (Section G): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer Contact: daniel doerr ; 6869 stapoint court; suite 114; winter park, FL 32792
• MDR Report Key: 8903470
• MDR Text Key: 191569455
• Report Number: 3002590791-2019-00008
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: 00877972004004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 550-000-003
• Device Catalogue Number: 550-000-003
• Device Lot Number: I9879-I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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