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

Model Number 21-345

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 06/27/2018

Event Type  malfunction  

Event Description

When cleaning trocar port, the trocar wipe came off the cleaner stick and fell into the thoracic cavity.Doctor retrieved missing sponge cleaner tip.The tip was matched to the end of the cleaner stick.No other pieces were missing.Port cleaner and box bagged and given to manager.It appears the foam tip of the wipe was torn off.

• Brand Name: CLEARIFY
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 7685117
• MDR Text Key: 113895753
• Report Number: 7685117
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: P8B1470HX
• 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: 07/05/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA