MAUDE Adverse Event Report: COOK MEDICAL 4, 6, 10 SHOOTER; HEMORRHOID BAND

Lot Number W370613

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2016

Event Type  malfunction  

Event Description

Band ligator did not deploy bands, equipment removed and replaced with new kit; procedure completed without harm to pt or other complications.

• Brand Name: 4, 6, 10 SHOOTER
• Type of Device: HEMORRHOID BAND
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 5702685
• MDR Text Key: 46767437
• Report Number: MW5062669
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: W370613
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 92