MAUDE Adverse Event Report: COOK MEDICAL COOK MULTIBAND LIGATOR MBL-6-OV

Lot Number 3357196

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 03/05/2014

Event Type  Injury  

Event Description

Patient undergoing egd.Banding device came off the scope.Ligator noted to be missing when physician attempted to band varices.Device and several bands found in the back of the oral pharynx.Stat pulmonary consult was obtained, patient has intubated, and device and bands were able to be retrieved.

• Brand Name: COOK MULTIBAND LIGATOR MBL-6-OV
• Type of Device: MULTIBAND LIGATOR
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402 419
• MDR Report Key: 3693140
• MDR Text Key: 4256531
• Report Number: MW5035072
• Device Sequence Number: 1
• Product Code: MND
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3357196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR