MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME ELITE; ELITE PROBE - REFRESH

Model Number	MEP10
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devicor's mammotome elite biopsy system is composed of a holster and a probe.The system may also include the use of the optional accessory (the introducer stylet) to initiate the track within the breast tissue to the biopsy site (refer to introducer stylet ifu for details).The mammotome elite system may be used with the ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the probe.The components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure.The holster, reusable and supplied non-sterile, is self-contained, handheld, electro-mechanical, vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes a charging base with an ac power cord and adapters.According to the reporter, this event occurred after breast biopsy procedure.After the biopsy, there was a piece of plastic in the sample cup.The procedure was completed.There was no patient complication.The mep10 will not be returned for evaluation.The investigation is pending the return and evaluation of foreign material.
Event or Problem Description
According to the reporter, this event occurred after breast biopsy procedure.After the biopsy, there was a piece of plastic in the sample cup.The procedure was completed.There was no patient complication.
Additional Manufacturer Narrative
The initial report was submitted 02-jan-2025.D1 brand name had a spelling error.G1 contact office - manufacturing site had the incorrect state abbreviation listed.G2 type of report should have had both initial and 30-day boxes checked.The device was not available for return.Despite being returned for investigation, cg labs nor mammotome has received the device preventing an analysis of the material.Mammotome tijuana performed an evaluation of the manufacturing process.It was observed that during the assembly process, fragments of "flash" were found on several raw material components: basket catch, housing back cup and housing front cup.The most probable root cause is that the raw material is the contributor of the reported condition since it was observed that there was loose or embedded flash.With the analysis and the raw material inspection that was carried out, plastic particles were found.Containment actions have been put in place to prevent this event from re-occurring.
Additional Manufacturer Narrative
The initial report was submitted on 02-jan-2025.D4 serial number was filled out and should have been blank.D4 lot number should have been filled out.Follow up #1 was submitted on 30-jan-2025.H11 additional manufacturer narrative mentions "g2 type of report should have had both initial and 30-day boxes checked." the purpose of this follow up (#2) report is to correct d4 from the initial report and h11 from the follow up #1 report.
Additional Manufacturer Narrative
Follow up #2 was submitted on 23-apr-2025.H11 additional manufacturer narrative stated, "follow up #1 was submitted on 30-jan-2025.H11 additional manufacturer narrative mentions g2 type of report should have had both initial and 30-day boxes checked." this statement in follow up #2 report is a typo."g2" should have stated "g6".

• Brand Name: MAMMOTOME ELITE
• Common Device Name: ELITE PROBE - REFRESH
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; tijuana, mx 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; sor juanaines de la cruz; #20152 4-b; tijuana, bc, OH 22440 ; MX 22440
• MDR Report Key: 21056770
• Report Number: 3008492462-2024-00011
• Device Sequence Number: 15617502
• Product Code: KNW
• UDI-Device Identifier: 00841911102793
• UDI-Public: (01)00841911102793(10)F12416429D(17)260425
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2025

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: 04/25/2026
• Device Model Number: MEP10
• Device Catalogue Number: CA000137013
• Device Lot Number: F12416429D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/30/2025; 04/23/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown