MAUDE Adverse Event Report: WILSON-COOK MEDICAL COOK MEDICAL SPHINCTEROTOME; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number FS-OMNI-21-260

Device Problems Fracture (1260); Failure to Cut (2587); Sparking (2595)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2019

Event Type  Injury  

Event Description

During an ercp the physician was using the fusion omni-tome pre-loaded sphincterotome, when according to the surgeon it failed to cut so he changed to a boston scientific microknife xl along with a cook medical roadrunner guide wire connected to a bovi during the sphincterotomy when he initiated the bovi there was a spark at the surgical site and a small segment of guidewire was fractured and retained within the dorsal pancreatic duct.Fda safety report id(s)# (b)(4).

• Brand Name: COOK MEDICAL SPHINCTEROTOME
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): WILSON-COOK MEDICAL ; winston salem NC 27105
• MDR Report Key: 9128831
• MDR Text Key: 160528203
• Report Number: MW5090076
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2023
• Device Model Number: FS-OMNI-21-260
• Device Catalogue Number: G56103
• Device Lot Number: W4233633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR