MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521230

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

The rn removed the resolution clip for hemostasis out of the package and inspected the clip for proper position prior to insertion of device into working channel.When inspected it was observed that the first clip did not have a clip attached.Device was not used on patient.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7929453
• MDR Text Key: 122485023
• Report Number: 7929453
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Device Catalogue Number: M00521230
• Device Lot Number: 0000101885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1