MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. SAEED; LIGATOR, ESOPHAGEAL

Model Number G31917

Device Problems Partial Blockage (1065); Retraction Problem (1536); Material Twisted/Bent (2981)

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

Event Date 07/10/2019

Event Type  malfunction  

Event Description

While setting up for deployment to treat esophageal varices, the band coiled up and retracted into endoscopy scope pcf #72.The scope and bander were no longer functional, since the band clogged up the scope.We switched to another scope and different bander to complete the procedure.There were no patient complications.Manufacturer response for ligator, esophageal, saeed (per site reporter): endoscopy called the vendor, who replied they will report this and investigate.

• Brand Name: SAEED
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; 4900 bethania station rd; winston salem NC 27105
• MDR Report Key: 8806916
• MDR Text Key: 151588883
• Report Number: 8806916
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002319172
• UDI-Public: (01)00827002319172(17)200528(10)W4219950
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G31917
• Device Catalogue Number: MBL-U-6
• Device Lot Number: W4219950
• 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: 07/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 112