FDA Adverse Event Malfunction Summary report: N

8G X 12 MAMMOTOME REVOLVE ULTRASOUND PROBE

MDR report key: 9132513 · Received September 29, 2019

Report

Report Number: 3008492462-2019-00044
Event Type: Malfunction
Date Received: September 29, 2019
Date of Event: August 29, 2019
Report Date: September 27, 2019
Manufacturer: DEVICOR MEDICAL PRODUCTS, INC
Product Code: KNW
UDI-DI: 00841911100812
PMA / PMN Number: K152989
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MAMOTOME REVOLCE DUAL VACUUM ASSISTED BIOPSY SYSTEM IS INTENDED TO OBTAIN TISSUE SAMPLES FROM THE BREAST OR AXILLARY NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE WAS NOT RETURNED TO DEVICOR MEDICAL PRODUCTS, INC. FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED INCIDENT. IF THE TISSUE IS FOUND WITHIN THE VACUUM TUBING RATHER THAN IN THE SAMPLE MANAGEMENT SYSTEM, A MISDIAGNOSIS IS POSSIBLE DUE TO LOST TISSUE. FOLLOWING CONSULTATION WITH OUR MEDICAL DIRECTOR, DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AS A RESULTS OF POTENTIAL MISSED OR LOST TISSUE SAMPLES, PURSUANT TO 21 CFR 803, THIS FAILURE MODE WAS DETERMINED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem · 1

IT WAS REPORTED BY AFFILIATE DURING PROCEDURE THE NEEDLE DID NOT TAKE THE SPECIMENS, THE PREPARATIONS WERE IN THE SUCTION TUBES AND IN THE NEEDLE PATH. AFTER REMOVING THE NEEDLE FROM THE BREAST, THE DOCTOR PUSHED THE PREPARATIONS THROUGH THE PLACE OF APPLICATION OF THE MARKER. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS. RECORD# (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
926611	8G X 12 MAMMOTOME REVOLVE ULTRASOUND PROBE	BIOPSY SYSTEM, PRODUCT CODE: KNW	KNW	DEVICOR MEDICAL PRODUCTS, INC	MHUS08	F11917470D	00841911100812

Patients

Seq	Age	Sex	Outcome	Treatment
1