MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOTOME REVOLVE® DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM; BIOPSY INSTRUMENT

Model Number MSTH1

Device Problem Use of Device Problem (1670)

Patient Problem Electric Shock (2554)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

The mammotome revolve® dual vacuum assisted biopsy (vab) system is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.The msth1 holster was returned to devicor for evaluation.The device passed all testing criteria and produced no errors.A discoloring on the tactical switch was observed, typically seen with a 602 error, reflective of a holster communication error, although no errors were noted to have occurred.There was no smell of smoke noted during the device evaluation.

Event Description

Devicor medical products inc.Received a report from user facility stating, "holster started producing smokey smell during a biopsy.They tested it out again and it smelled like smoke.The tech then picked up the holster and it shocked her several times".The technician reported pain and numbness in her arm for the duration of approximately one hour following the incident.The technician declined medical intervention.Multiple attempts have been made to get additional information regarding the reported shocks.This has been documented in our complaint systems as record # (b)(4).

• Brand Name: MAMMOTOME REVOLVE® DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): PLEXUS; 2400 millbrook drive; buffalo grove IL 60089
• Manufacturer Contact: jill burnett ; 300 e. business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 8588927
• MDR Text Key: 144405696
• Report Number: 3008492462-2019-00020
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00841911101895
• UDI-Public: (01)00841911101895
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSTH1
• Device Catalogue Number: MSTH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1