MAUDE Adverse Event Report: COVIDIEN CLEARIFY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 21-345

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Device busted open on sterile field during surgical procedure.

• Brand Name: CLEARIFY
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9139556
• MDR Text Key: 160711102
• Report Number: 9139556
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-345
• Device Lot Number: D8M0775Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1