MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number INSC-P-7-230-S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

Removed device from package, prior to attempting to insert into scope the clip fell off the device.Another device was opened/used.

• Brand Name: COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.
• MDR Report Key: 16631120
• MDR Text Key: 312305636
• Report Number: MW5116049
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSC-P-7-230-S
• Device Catalogue Number: G58010
• Device Lot Number: W4642197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White