MAUDE Adverse Event Report: COOK INCORPORATED INSTINCT; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number G58010

Device Problems Break (1069); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Cook hemoclips broke before deployment; clip "fell off.".

• Brand Name: INSTINCT
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 16511964
• MDR Text Key: 310964545
• Report Number: 16511964
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)251121(10)W4658548
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4658548
• 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: 02/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Male
• Patient Weight: 96 KG