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

Model Number	550-000-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10361349
• Report Number: 3002590791-2020-00038
• Device Sequence Number: 2329718
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)I9824-A(11)180911(17)200310
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1