MAUDE Adverse Event Report: COOK / WILSON-COOK MEDICAL INC. INSTINCT HEMOCLIP ; LIGATOR, ESOPHAGEAL

Model Number INSC-7-230-S

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/30/2020

Event Type  malfunction  

Event Description

The provider tried to deploy the clip and it did not deploy.The tech was (b)(6) who brought this to the rn for quality in endoscopy.The clip and packaging were brought and a defective medical device from was completed and taken to materials management with the device.

• Brand Name: INSTINCT HEMOCLIP
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK / WILSON-COOK MEDICAL INC.
• MDR Report Key: 9933192
• MDR Text Key: 186825175
• Report Number: MW5094049
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSC-7-230-S
• Device Lot Number: W43179078
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR