10MM X 10MM X 10MM STAPLE 500-10-101 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-28 for 10MM X 10MM X 10MM STAPLE 500-10-101 NA manufactured by Trilliant Surgical.

MAUDE Entry Details

• Report Number: 3007420745-2020-00008
• MDR Report Key: 9638589
• Report Source: DISTRIBUTOR
• Date Received: 2020-01-28
• Date of Report: 2020-01-28
• Date of Event: 2019-12-26
• Date Mfgr Received: 2019-12-31
• Date Added to Maude: 2020-01-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. SOFIA MIDDLETON
• Manufacturer Street: 727 NORTH SHEPHERD DRIVE SUITE 100
• Manufacturer City: HOUSTON TX 770071320
• Manufacturer Country: US
• Manufacturer Postal: 770071320
• Manufacturer Phone: 7133886063
• Manufacturer G1: TRILLIANT SURGICAL
• Manufacturer Street: 727 NORTH SHEPHERD DRIVE SUITE 100
• Manufacturer City: HOUSTON TX 770071320
• Manufacturer Country: US
• Manufacturer Postal Code: 770071320
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 10MM X 10MM X 10MM STAPLE
• Generic Name: SNIPER STAPLE SYSTEM STAPLE
• Product Code: JDR
• Date Received: 2020-01-28
• Returned To Mfg: 2020-01-07
• Model Number: 500-10-101
• Catalog Number: NA
• Lot Number: SEE SECTION H10.
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TRILLIANT SURGICAL
• Manufacturer Address: 727 NORTH SHEPHERD DRIVE SUITE 100 HOUSTON TX 770071320 US 770071320

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-28