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

Model Number M00521230

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 06/03/2018

Event Type  malfunction  

Event Description

Following use and power cleaning of an olympus endoscope, a clip popped out of the channel.The endoscope in question had been used on two patients that day.Patient #1 involved the use of a clip and patient #2 did not.The device was cleaned without incident after use on patient #1.After use on patient #2, during the power scrub, a clip popped out.The scope was returned to olympus for preventive maintenance and found to be in working order with no defects.The equipment has been returned to inventory.Please see further detailed descriptions under patient #1 and #2.Manufacturer response for resolution 360 clip, resolution 360 clip (per site reporter): i do not believe the manufacturer of the clip was made aware of this event.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7673140
• MDR Text Key: 113523797
• Report Number: 7673140
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2018

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: No Information
• Device Model Number: M00521230
• Device Catalogue Number: M00521230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 83