FUSION WIRE GUIDE LOCKING DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for FUSION WIRE GUIDE LOCKING DEVICE manufactured by Wilson-cook Medical Inc..

Event Text Entries

[92977294] Pt was undergoing ercp and it was noted that a sponge was in the biopsy channel from a previous procedure. It is believed that the sponge material machines that of the biopsy cap. Scope was removed and new scope was utilized. Pt required no further treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073533
• MDR Report Key: 7057366
• Date Received: 2017-11-24
• Date of Report: 2017-11-21
• Date of Event: 2017-11-17
• Date Added to Maude: 2017-11-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: FUSION WIRE GUIDE LOCKING DEVICE
• Generic Name: FUSION WIRE GUIDE LOCKING DEVICE
• Product Code: DQX
• Date Received: 2017-11-24
• Lot Number: W3854576
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: WILSON-COOK MEDICAL INC.
• Manufacturer Address: WINSTON SALEM NC 27105 US 27105

Device Sequence Number: 1

• Brand Name: FUSION WIRE GUIDE LOCKING DEVICE
• Generic Name: FUSION WIRE GUIDE LOCKING DEVICE
• Product Code: HOZ
• Date Received: 2017-11-24
• Lot Number: W3854576
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WILSON-COOK MEDICAL INC.
• Manufacturer Address: WINSTON SALEM NC 27105 US 27105

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-11-24