MAUDE Adverse Event Report: BOSTON SCIENTIFIC RESOLUTION CLIP

Model Number M00522610

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2016

Event Type  malfunction  

Event Description

During endoscopy procedure the clip was deployed but did not grasp the margins.The clip was removed from the patient with no harm.

• Brand Name: RESOLUTION CLIP
• Type of Device: RESOLUTION CLIP
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 6202186
• MDR Text Key: 63316370
• Report Number: MW5066892
• Device Sequence Number: 1
• Product Code: PKL
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00522610
• Device Lot Number: M1001349CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 73