MAUDE Adverse Event Report: BOSTON SCIENTIFIC RESOLUTION 360 CLIP

Catalog Number M00521230

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/21/2017

Event Type  malfunction  

Event Description

Clip placed through scope.Clip opened by the technician and it fell off the device.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: RESOLUTION 360 CLIP
• Manufacturer (Section D): BOSTON SCIENTIFIC; jeffersonville IN 47130
• MDR Report Key: 6746497
• MDR Text Key: 81287224
• Report Number: MW5071259
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• 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: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Catalogue Number: M00521230
• Device Lot Number: 0000067167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 121