MAUDE Adverse Event Report: TELEMED SYSTEMS INC. TELEMED CYTOLOGY BRUSH; CVYTOLOGY BRUSH

Model Number 3014

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 01/21/2015

Event Type  Injury  

Event Description

Patient developed pneumothorax subsequent to endoscopic use of cytology brush to obtain sample from right lung.

Manufacturer Narrative

Device was returned on 2/19/2015; no evaluation performed yet.Will file follow-up report with results of evaluation.

Manufacturer Narrative

Device was examined by dr.(b)(6) ((b)(6)).The device was intact with no missing pieces or components.Mechanical function of bruch and handle were normal and functioned according to manufacturing specifications; no device malfunction was detected.

Event Description

Patient developed pneumothorax subsequent to endoscopic use of cytology brush to obtain sample from right lung.

• Brand Name: TELEMED CYTOLOGY BRUSH
• Type of Device: CVYTOLOGY BRUSH
• Manufacturer (Section D): TELEMED SYSTEMS INC.; 8 kane industrial drive; hudson MA 01749
• Manufacturer (Section G): TELEMED SYSTEMS INC.; 8 kane industrial drive; hudson MA 01749
• Manufacturer Contact: delia chaves ; 8 kane industrial drive; hudson, MA 01749 ; 5085679033
• MDR Report Key: 4533704
• MDR Text Key: 15114469
• Report Number: 1222168-2015-00001
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 3014
• Device Catalogue Number: 3104
• Device Lot Number: K13683104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BRONCHOSCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR