FDA Adverse Event Injury Summary report: N

SUPERDIMENSION INREACH BRONCHUS SYSTEM

MDR report key: 4927539 · Received July 21, 2015

Report

Report Number: 3004962788-2015-00050
Event Type: Injury
Date Received: July 21, 2015
Date of Event: June 24, 2015
Report Date: August 14, 2015
Manufacturer: SUPERDIMENSION INC.
Product Code: JAK
PMA / PMN Number: K092365
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COVIDIEN REFERENCE # : (B)(4); DATE OF INITIAL REPORT : 07/21/2015; DATE OF FOLLOW-UP REPORT : 08/14/2015. A COMPONENT OF THE SUPERDIMENSION SYSTEM CASE RECORDINGS, WAS RETURNED AND EVALUATED AND NOTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S REPORT WAS FOUND. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

A COMPONENT OF THE SUPERDIMENSION SYSTEM, CASE RECORDINGS, HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. PNEUMOTHORAX 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.

Description of Event or Problem · 1

THE PATIENT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE. THE PATIENT RECEIVED A PIGTAIL CATHETER AND WAS HOSPITALIZED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
471525	SUPERDIMENSION INREACH BRONCHUS SYSTEM	ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY	JAK	SUPERDIMENSION INC.	AAS00161-12

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O\| R