MAUDE Adverse Event Report: SUPERDIMENSION INC. GENCUT CORE BIOPSY SYSTEM

Model Number SDCT01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.There was no lot number provided therefore a dhr review was could not be completed.Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If additional information is received a follow-up report will be submitted.

Event Description

After using gencut during a superdimension enb procedure, the patient experienced bleeding.The patient was moved to icu after procedure.No further information is known.If additional information is received a follow-up report will be submitted.

• Brand Name: GENCUT CORE BIOPSY SYSTEM
• Type of Device: CORE BIOPSY SYSTEM
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 5653661
• MDR Text Key: 45150791
• Report Number: 3004962788-2016-00113
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142839
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDCT01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other