MAUDE Adverse Event Report: GENICON, INC. AL-LI-GATOR; IMPLANTABLE CLIP

Model Number	350-000-103
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This reportable injury was identified during a review of complaints received between october 2017 and december 2019.Through review and communication from the surgeon, the likely cause is that a larger clip should have been used on the vessel.The two suspect clip appliers were returned to genicon, and found to function normally; there were misalignments or other issues present.
Event or Problem Description
Distributor has received complaints from their customers that clips, part number 350-000-103 and lot number 026214, which they purchased in (b)(6) (2018) aren't safe because they torn and make traumas in arteries and bile ducts.They caused a lot of bleedings inside the body.Customer believes the clip applier is either part number 350-010-002, lot number 07161229 or lot number 07161230.

• Brand Name: AL-LI-GATOR
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10253583
• Report Number: 3002590791-2020-00036
• Device Sequence Number: 3484601
• Product Code: FZP
• UDI-Device Identifier: 00877972004554
• UDI-Public: (01)00877972004554(10)026214(11)181207(17)211206
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K100090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 12/06/2021
• Device Model Number: 350-000-103
• Device Lot Number: 026214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 07/09/2020
• 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