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

Model Number	MEP13
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
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.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.
Event or Problem Description
It was reported by the affiliate that after the sampling, there was considerable bleeding when the needle was removed from the patient.When the doctor looked at the needle tip, the tip was bent.This incident is documented as complaint (b)(4).No serious injury occurred.

• 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: 10875454
• Report Number: 3008492462-2020-00010
• Device Sequence Number: 16895360
• Product Code: KNW
• UDI-Device Identifier: 00841911100898
• UDI-Public: (01)00841911100898(17)240120(10)F12003405D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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 Expiration Date: 01/20/2024
• Device Model Number: MEP13
• Device Catalogue Number: MEP13
• Device Lot Number: F12003405D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1