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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
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.
 
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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 Key7673140
MDR Text Key113523797
Report Number7673140
Device Sequence Number1
Product Code PKL
Combination Product (y/n)N
Number of Events Reported1
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 NumberM00521230
Device Catalogue NumberM00521230
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer07/10/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age17155 DA
Patient Weight83
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