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

Model Number 550-000-008

Device Problems Material Rupture (1546); Material Separation (1562)

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

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between october 2017 through december 2019.The device was not returned to genicon, inc.

Event Description

"today, one of the samples for ref # (b)(4) was tried because it is a bigger bag.Subsequently, there are some major concerns related to the design, and even more concerning, the quality of the product.The bag completely tore off from the string.The bag and the specimen had to be retrieved.The tapered or semicircular cut of the distal portion of the bag is not useful.The opening isn't large enough to adequately accommodate the specimens.Therefore, purely as a patient safety issue related to the complete failure of this item and the overall lack of utility with the other retriever sizes, we will not be ordering any more of these items in the foreseeable future.As far as i can tell, the lot number involved is 19614-g.Unfortunately, the defective unit was tossed in the trash and is unavailable." per email from (b)(6) - pmi sales rep: "good afternoon.Here is the info i know.Product information: was this a single use device that had been reprocessed? new sterile sample.Event information: was there a patient injury? if yes, what is status of patient now? no.Was there a delay in procedure? yes, since they had to retrieve bag, as indicated in per.If yes, did the delay impact patient safety? no.How was the procedure completed? (i.E.Another genicon unit or a competitor's product)they fished the bag out.Can you provide any more detail on the incident itself? what type of procedure, specimen, etc.What other devices were being used.Did the surgeon enlarge the site, how large was the port site? unknown.Has the surgeon used our products before? no.If no, was in-service provided prior to the case? yes, by the crd.I was in (b)(6) on a different genicon evaluation.This is any additional info i have that may or may not have been covered in the per.".

Manufacturer Narrative

Corrected (date of event), updated (date of this report), (udi), (follow up 001), (correction).

• Brand Name: GENICON GENISTRONG RETRIEVAL BAG, XL
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10378827
• MDR Text Key: 209433663
• Report Number: 3002590791-2020-00058
• 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
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

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: 10/23/2021
• Device Model Number: 550-000-008
• Device Lot Number: I9614-G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1