MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; LIGATOR, HEMORRHOIDAL

Catalog Number M00522610

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

Upon application of endoscopy clip, the boston scientific resolution clip engaged but would not release from tissue.The handle on the applier broke into pieces.The wire was visible and moved until the clip released from the tissue.The clip and applier were removed from the patient via the endoscope by the doctor.
=
manufacturer response for resolution clip, resolution clip (per site reporter).
=
the manufacturer has not completed their investigation.

• Brand Name: RESOLUTION CLIP
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 4773579
• MDR Text Key: 5781953
• Report Number: 4773579
• Device Sequence Number: 1
• Product Code: FHN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: M00522610
• Device Lot Number: ML000933C3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 85