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

Model Number M00522610

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Reported: "i ensured the clip appeared normal via visual inspection, then i inserted the clip down the biopsy channel of the endoscope.I opened the clip and then closed it on the patient's mucosa in the colon when asked to by the physician.I was told to deploy the clip and pulled the handle back until the clip made an audible deployment noise.When i pulled the device back out of the endoscope, i noticed the clip portion did not deploy and was still attached to the device".

• Brand Name: RESOLUTION 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: 16484927
• MDR Text Key: 310693919
• Report Number: 16484927
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00522610
• Device Lot Number: 28020716
• 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: 02/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White