TBL FIX STPL DRVR-EXTRAC 111130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-05 for TBL FIX STPL DRVR-EXTRAC 111130 manufactured by Brooks Manufacturing Site.

Event Text Entries

[1080837] It was reported that the device fractured during removal of the staple and part of the device was left in the pt.
Patient Sequence No: 1, Text Type: D, B5

[8178498] Na
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2009-00510
• MDR Report Key: 1335102
• Report Source: 07
• Date Received: 2009-03-05
• Date of Report: 2009-03-02
• Date of Event: 2009-01-27
• Date Mfgr Received: 2009-02-27
• Date Added to Maude: 2009-03-10
• 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: 0
• Event Location: 0
• Manufacturer Contact: MR. JERRY HOWARD
• Manufacturer Street: 1450 BROOKS RD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996153
• Manufacturer G1: BROOKS MANUFACTURING SITE
• Manufacturer Street: 1450 BROOKS RD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: STAPLE DRIVER/ EXTRACTOR/ HXJ
• Product Code: HXJ
• Date Received: 2009-03-05
• Model Number: TBL FIX STPL DRVR-EXTRAC
• Catalog Number: 111130
• Lot Number: HT05001
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BROOKS MANUFACTURING SITE
• Manufacturer Address: MEMPHIS TN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-03-05