COOK MEDICAL SPHINCTEROTOME FS-OMNI-21-260 G56103

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for COOK MEDICAL SPHINCTEROTOME FS-OMNI-21-260 G56103 manufactured by Wilson-cook Medical.

MAUDE Entry Details

• Report Number: MW5090076
• MDR Report Key: 9128831
• Date Received: 2019-09-26
• Date of Report: 2019-09-25
• Date of Event: 2019-09-18
• Date Added to Maude: 2019-09-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• 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: 1

• Brand Name: COOK MEDICAL SPHINCTEROTOME
• Generic Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Product Code: KNS
• Date Received: 2019-09-26
• Model Number: FS-OMNI-21-260
• Catalog Number: G56103
• Lot Number: W4233633
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WILSON-COOK MEDICAL
• Manufacturer Address: WINSTON SALEM NC 27105 US 27105

Device Sequence Number: 2

• Brand Name: MICROKNIFE XL
• Generic Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Product Code: KNS
• Date Received: 2019-09-26
• Model Number: GTIN 08714729172017
• Catalog Number: M00532810
• Lot Number: 22945338
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORPORATION

Device Sequence Number: 3

• Brand Name: ROADRUNNER WIRE GUIDE
• Generic Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY - UROLOGY
• Product Code: OCY
• Date Received: 2019-09-26
• Model Number: RR-18-260
• Catalog Number: G23038
• Lot Number: W4021551
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COOK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-26