MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. HERCULES; DILATOR, ESOPHAGEAL

Model Number G48732

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

While using a dilation balloon, equipment failed to stay dilated during procedure.The dr.Wanted to make sure the company was aware of faulty product.

• Brand Name: HERCULES
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; 4900 bethania station rd; winston salem NC 27105
• MDR Report Key: 7804300
• MDR Text Key: 117850074
• Report Number: 7804300
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G48732
• Device Catalogue Number: HBD-15-16.5-18
• Device Lot Number: W4063645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2018
• Date Report to Manufacturer: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA