MAUDE Adverse Event Report: COOK MEDICAL SIX SHOOTER SAEED MULTI-BAND LIGATOR

Model Number G22553

Device Problem Misfire (2532)

Patient Problem No Information (3190)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

During endoscopy procedure, the six shooter bands kept misfiring and not attaching.Discarded device and a new one time use multi-band ligator was used with no problems to finish the procedure.

• Brand Name: SIX SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: LIGATOR
• Manufacturer (Section D): COOK MEDICAL; 4900 bethania station rd.; winston-salem NC 27105
• MDR Report Key: 4330406
• MDR Text Key: 5212605
• Report Number: MW5039548
• Device Sequence Number: 1
• Product Code: FHN
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: G22553
• Device Lot Number: W3489037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1