MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC NEEDLE TIP CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Lot Number 023727

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

Unable to locate the model number from the lot number, possible incorrect lot number.The device was not returned for evaluation.Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during fluoroscopic evaluation of the patient in an enb procedure, the site noted a tiny pneumothorax.There was no intervention required and the pneumothorax was considered resolved at the time of discharge.The patient was listed as a known complication of transbronchial brushing.There were no issues reported with endoscopic tool or the system.

• Brand Name: NEEDLE TIP CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 7632104064
• MDR Report Key: 7826008
• MDR Text Key: 118528814
• Report Number: 3004962788-2018-00045
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K834402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018

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: Health Professional
• Device Lot Number: 023727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/29/2018
• 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
• Treatment: SUPERDIMENSION INREACH SYSTEM
• Patient Outcome(s): Other