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

Model Number	MEP10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mep10 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 event occurred during breast biopsy procedure.After the tissues were collected, the sample cup was opened and a piece of plastic was found, which was not noticed during priming.The size of the foreign object was about 5 millimeters.The procedure was completed.There was no patient complication.To date, we have requested the return of the device to further evaluate any other potential root causes.
Event or Problem Description
According to the reporter, the event occurred during breast biopsy procedure.After the tissues were collected, the sample cup was opened and a piece of plastic was found, which was not noticed during priming.The size of the foreign object was about 5 millimeters.The procedure was completed.There was no patient complication.
Event or Problem Description
According to the reporter, the event occurred during breast biopsy procedure.After the tissues were collected, the sample cup was opened and a piece of plastic was found, which was not noticed during priming.The size of the foreign object was about 5 millimeters.The procedure was completed.There was no patient complication.
Additional Manufacturer Narrative
Mep10 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 event occurred during breast biopsy procedure.After the tissues were collected, the sample cup was opened and a piece of plastic was found, which was not noticed during priming.The size of the foreign object was about 5 millimeters.The procedure was completed.There was no patient complication.The device and foreign material were returned for investigation.Upon investigation: 1.The foreign material and subsurface skive of the mep10 probe cup were examined for compatibility.Investigation confirmed that the foreign object material was not equivalent to the mep10 probe cup and did not originate from it.2.The mep10 packaging material was also tested and examined for compatibility.Investigation confirmed that the foreign object material was not equivalent to the mep10 packaging sample and did not originate from it.3.The mep10 device was evaluated and there were no signs of damage or plastic shavings on the device.Based on the investigation findings there is no evidence that the foreign material came from the device involved in this incident and there is no conclusive evidence the foreign material came from our manufacturing site.A review of the complaint database was performed and there were no other complaints reported against this lot number.Although there is no evidence of serious injury and no evidence of device malfunction.This incident is being reported due to the the allegation of malfunction and inconclusive investigation results.
Additional Manufacturer Narrative
The initial report was submitted on 24-aug-2024.The purpose of this follow up report (follow-up #2) is to correct/clarify initial and follow up reports previously submitted.Corrections that should have been applied to initial report: d4 serial & lot number- the number documented under "serial number" should have documented under "lot number".Corrections that should have been applied to follow up #1: h2- missing follow up report type (device evaluation), and h3 should state "yes", "device evaluation anticipated, but not yet begun" removed.Since this was a follow-up, the report should have only contained new information in cells: b4, d9, g6, g8, h2, h3, h6 (updated investigation codes only), h10 with updated new information only.The corrections mentioned above are being submitted in this report (follow-up #2).

• 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
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 17613006
• Report Number: 3008492462-2023-00010
• Device Sequence Number: 7446183
• Product Code: KNW
• UDI-Device Identifier: 10841911100888
• UDI-Public: (01)10841911100888(17)231025(10)F12142351D
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2024

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
• Device Expiration Date: 10/25/2023
• Device Model Number: MEP10
• Device Lot Number: F12142351D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 07/25/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/28/2023; 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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