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

Model Number	MSTH1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8588927
• Report Number: 3008492462-2019-00020
• Device Sequence Number: 19249255
• Product Code: KNW
• UDI-Device Identifier: 00841911101895
• UDI-Public: (01)00841911101895
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1