ACROBAT? 2 CALIBRATED TIP WIRE GUIDE AWG2-35-450

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-03 for ACROBAT? 2 CALIBRATED TIP WIRE GUIDE AWG2-35-450 manufactured by Cook Endoscopy.

MAUDE Entry Details

• Report Number: 1037905-2020-00059
• MDR Report Key: 9662218
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-03
• Date of Report: 2020-01-09
• Date of Event: 2020-01-08
• Date Mfgr Received: 2020-02-10
• Device Manufacturer Date: 2019-05-28
• Date Added to Maude: 2020-02-03
• 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: MS. SCOTTIE FARIOLE
• Manufacturer Street: 4900 BETHANIA STATION RD
• Manufacturer City: WINSTON-SALEM NC 27105
• Manufacturer Country: US
• Manufacturer Postal: 27105
• Manufacturer Phone: 3367440157
• Manufacturer G1: COOK ENDOSCOPY
• Manufacturer Street: 4900 BETHANIA STATION RD
• Manufacturer City: WINSTON-SALEM NC 27105
• Manufacturer Country: US
• Manufacturer Postal Code: 27105
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACROBAT? 2 CALIBRATED TIP WIRE GUIDE
• Generic Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Product Code: OCY
• Date Received: 2020-02-03
• Returned To Mfg: 2020-02-10
• Catalog Number: AWG2-35-450
• Lot Number: W4215221
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK ENDOSCOPY
• Manufacturer Address: 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-03