MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME ELITE BIOPSY PROBE; BIOPSY INSTRUMENT

Model Number	MEP13
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mep13 probes are sterile, single use devices, indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.One mep13 device was returned for investigation.The device was evaluated and found to be unable to pull saline.The device was disassembled to look for leaks or blockages.Breast tissue was found in the needle.The needle was cleared and the device when reassembled was able to obtain 3/3 samples of chicken.Due to the discovery of the tissue, this event was assessed against the result of the investigation.Following consultation with our medical director, due to the potential to cause or contribute to death or serious injury as a result of potential missed or lost tissue samples, pursuant to 21 cfr §803, this failure mode was determined to be a reportable malfunction.
Event or Problem Description
Devicor medical products, inc.Received a report from a user facility stating, the elite would not suction per the nurse but then started making a hissing noise and it got clogged.Sample was not adequate, but sent to pathology.The procedure was completed with the original device.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME ELITE BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8634166
• Report Number: 3008492462-2019-00025
• Device Sequence Number: 2017254
• Product Code: KNW
• UDI-Device Identifier: 00841911100744
• UDI-Public: (01)00841911100744(17)211130(10)F11848412D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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 Expiration Date: 11/30/2021
• Device Model Number: MEP13
• Device Catalogue Number: MEP13
• Device Lot Number: F11848412D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1