MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR

Model Number MBL-6-OV

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem No Information (3190)

Event Date 12/29/2015

Event Type  Injury  

Event Description

Banding mechanism did not deploy appropriately. Banding was unsuccessful.

• Brand Name: COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: BAND LIGATOR
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston salem NC 27105
• MDR Report Key: 5427728
• MDR Text Key: 37976435
• Report Number: MW5060087
• Device Sequence Number: 1
• Product Code: FER
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MBL-6-OV
• Device Lot Number: W3650380
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/05/2016 Patient Sequence Number: 1