MAUDE Adverse Event Report: GENICON, INC. GENICON 2EZEE SPECIMEN RETRIEVAL BAG

Model Number 550-000-200

Device Problem Material Rupture (1546)

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

Event Date 04/02/2019

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 for evaluation.It should be noted that there were two (2) additional complaints included as part of the original complaint record.This complaint record ((b)(4)) was addended to focus on product experience report (b)(4).Complaint (b)(4) was initiated to address (b)(4) was initiated to address (b)(4).

Event Description

I met with doctor and reviewed the bag with him - he did hands-on and said it looked fine.I was available on 3/25-3/29, for doctor's cases, however this case was pushed and i was not made aware of the new date and time and was not present due to genicon evaluations at other facilities.Doctor did one other case with the bag and it worked as expected.I was told by the crd that after a different doctor had a tear (described in (b)(4)), that this doctor also had a similar tear - at the seam toward the bottom or point of the bag.Note: i have been present for 4 additional cases since this occurrence and the bag worked well, however i have not spoke to dr.Hipp at this time and will do so when he returns.((b)(4)).It should be noted that there were two (2) additional complaints included as part of the original complaint record.This complaint record was addended to focus on product experience report (b)(4).Complaint (b)(4) was initiated to address p(b)(4) was initiated to address (b)(4).

• Brand Name: GENICON 2EZEE SPECIMEN RETRIEVAL BAG
• Type of Device: SPECIMEN RETRIEVAL BAG
• 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: 10361349
• MDR Text Key: 205322652
• Report Number: 3002590791-2020-00038
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)I9824-A(11)180911(17)200310
• 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: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/03/2020

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: 03/10/2020
• Device Model Number: 550-000-200
• Device Lot Number: I9824-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1