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

Model Number M00521230

Device Problems Break (1069); Misfire (2532); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

The clip misfired before ready.When attempting to remove the resolution clip to retrieve the foreign body, the clip would not come out of the scope.This resulted in a piece of the scope breaking off into the patient's colon.With some teamwork, the piece of the scope and clip were removed from the patient without patient injury.

• 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: 12589752
• MDR Text Key: 275202009
• Report Number: 12589752
• 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: 10/05/2021

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 Lot Number: 2608223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1