MAUDE Adverse Event Report: US SURGICAL PUERTO RICO CLEARIFY; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number 21-345

Device Problem Detachment Of Device Component (1104)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/22/2017

Event Type  Injury  

Event Description

According to the reporter, during a lap cholecystectomy procedure, prior to the incision, a scrub put the laparoscopic trocar in the visualization system.The surgeon removed the trocar from the visualization system and put the scope in.A piece of plastic was visualized on the monitor and removed from the patient's abdomen.Upon investigation, the lumen of the visualization system was found to have a piece missing.The supervisor was notified, x-rays were taken and cleared by doctors.No foreign body was left behind.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLEARIFY
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6503083
• MDR Text Key: 73115837
• Report Number: 2647580-2017-05310
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 78