MAUDE Adverse Event Report: COOK INC. INTINCT ENDOSCOPIC HEMOCLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number 230-S

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Event Description

Clips failed to deploy during procedure x 2.Same lot numbers for both.

• Brand Name: INTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): COOK INC.; 6300 n. matthews dr.; bloomington, IN 47429
• MDR Report Key: 5623588
• MDR Text Key: 44143701
• Report Number: 5623588
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2019
• Device Model Number: 230-S
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: 247613
• Other Device ID Number: G18343
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR