Mammotome elite MEP13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841911100898), received between Jun 15, 2017 and Nov 20, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Material Twisted/Bent; Material Twisted/Bent

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10875454 ↗
• MalfunctionMay 10, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(4), STATING, "NO TISSUE SAMPLE ACQUIRED. THE NEW PROBE WAS USED AND THE PROCEDURE WAS COMPLETED". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599310 ↗
• MalfunctionFeb 12, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM OUR AFFILIATE IN (B)(6), STATING, DURING PROCEDURE NO TISSUE WAS ACQUIRED. THIS IS DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333497 ↗
• MalfunctionFeb 12, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM OUR AFFILIATE IN (B)(4) STATING, THE PROCEDURE SAMPLE BUTTON WAS NOT AVAILABLE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332976 ↗
• MalfunctionFeb 11, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM OUR AFFILIATE IN (B)(4) STATING, NO TISSUE WAS ACQUIRED DURING THE BIOPSY PROCEDURE. NO PATIENT IMPACT. THIS IS DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8328806 ↗
• MalfunctionFeb 11, 2019Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE IN (B)(4) STATING, THE SAMPLE WAS CLOGGED IN THE CUTTER MECHANISM. THE USER INJECTED SALINE INTO THE APERATURE AND STILL NO TISSUE SAMPLE WAS RETURNED TO THE SAMPLE MANAGEMENT CUP. NO PATIENT COMPLICATIONS. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325503 ↗
• MalfunctionSep 6, 2018Failure to Obtain Sample; Output Problem; Failure to Obtain Sample; Output Problem

  DEVICOR MEDICAL PRODUCTS, INC. HAS RECEIVED A REPORT FROM THE SALES REPRESENTATIVE STATING, "DURING PROCEDURE MEP13 PROBE DID NOT PICK UP SAMPLES. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE". THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD # (B)(4) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850143 ↗
• MalfunctionSep 6, 2018Failure to Obtain Sample; Failure to Obtain Sample

  DEVICOR MEDICAL PRODUCTS, INC. HAS RECEIVED A REPORT FROM THE SALES REPRESENTATIVE STATING, "DURING THE PROCEDURE, THE MEP13 PROBE DID NOT PICK UP SAMPLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE". THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850121 ↗
• MalfunctionJun 15, 2017Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised; Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised

  THE SALES REP REPORTED A DAMAGED PROBE. THE CARTON WAS DAMAGED AND ONE OF THE PROBES WAS UNUSABLE. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644752 ↗