MAUDE Adverse Event Report: GENICON MEDIUM GENISTRONG SPECIMEN RETRIEVAL BAG

Model Number	550-000-003
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Genicon has completed a thorough review of all available records related to this device and associated lot numbers.Records indicate that these lots passed all manufacturing and quality control inspections.All raw materials used passed incoming quality control checks and no irregularities or abnormalities were found.Review of vigilance reports revealed that there have been no documented instances of this failure mode dating back to 2017 and this complaint represents the only known occurrence since this time.Unfortunately the suspect device was not able to be retained for evaluation and no pictures were provided for review.In the absence of the suspect devices and given the available information, the failure could not be confirmed and the exact root cause of this event could not be determined.Although the root cause remains unknown, it is important to note that the directions detailed in the instructions for use include steps to ensure proper bag closure.To ensure the bag is able to close properly the following warning is included "this device is not intended for use with any tissue that will not fit within the confines of the specimen bag and allow complete closure of the bag".To aid in closing the bag after the thumb ring/push-pull rod has been retracted, follow steps b-3 or c-3 (depending on your chosen removal method) "pull the closure suture until the bag is completely cinched closed".Care should be taken to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 provided narrative indicates that the patient developed a surgical site infection post operatively for which the exact cause could not be determined but may be related to spillage from the bag during extraction.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 or Problem Description
Per report provided on 8/6/2019: "from [sales] rep: during a lap appendectomy, dr.(b)(6) could not get the specimen bag to close tightly at the top.While removing the bag from the patient, some of the bags contents spilled.The patient later developed a surgical site infection.From [hospital staff]: we now have an infection on a lap appendectomy patient.Although it is difficult to determine the cause, the surgeon believes the culprit is spillage from the retrieval bag as the bag would not close appropriately.For this particular surgeon, this infection is his first lap appendectomy infection.".

• Brand Name: MEDIUM GENISTRONG SPECIMEN RETRIEVAL BAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 8939573
• Report Number: 3002590791-2019-00009
• Device Sequence Number: 335934
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: 00877972004004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 550-000-003
• Device Catalogue Number: 550-000-003
• Device Lot Number: I9950-I
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other