MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOTOME REVOLVE; BIOPSY INSTRUMENT

Model Number	MSTH1
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer's msth1 fired the needle immediately after arming the holster.No adverse event occured with the usage of this product.
Event or Problem Description
It was reported by the sales representative that before procedure, ie during set up, thier msth1 holster fired the needle immediately after arming the holster.No patient complications were reported.This incident has been recorded in complaint #(b)(4).

• Brand Name: MAMMOTOME REVOLVE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati, oh
• MDR Report Key: 9919074
• Report Number: 3008492462-2020-00005
• Device Sequence Number: 3131416
• Product Code: KNW
• UDI-Device Identifier: 00841911100706
• UDI-Public: (01)00841911100706(11)191125
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1