MAUDE Adverse Event Report: WILSON COOK MEDICAL; CLIP

Lot Number W3504989

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

A gastric polyp was removed with a hot snare.A need for a clip was identified by the md.A cook clip was clipped onto the bleeding site, but could not be deployed.Therefore required the tech to pull the clip off in order to remove the instrument from the scope.More clips were successfully placed with no harm to the patient.

• Brand Name: COOK MEDICAL
• Type of Device: CLIP
• Manufacturer (Section D): WILSON; winston-salem NC 27105
• MDR Report Key: 4684346
• MDR Text Key: 5677137
• Report Number: MW5042063
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: W3504989
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR