Fischer Cone Biopsy Excisor 900-151Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888937003710), received between Dec 18, 2019 and Apr 5, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K061651); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Break

  E-COMPLAINT-(B)(4). ADDITIONAL COMPLAINT IN REF. TO E-COMPLAINT-(B)(4). REPORT STATED "WE HAVE RECEIVE A VIGILANCE ABOUT FISHER CONE BIOPSY EXCISOR FROM (B)(6) HOSPITAL 4 FISHER CONE BIOPSY EXCISOR - MEDIUM ARE BROKEN DURING USE. THE HOSPITAL KEPT THE DEFECTIVE PRODUCTS FOR ANALYSIS". FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615235 ↗
• MalfunctionMar 25, 2021Break

  "WE HAVE RECEIVE A VIGILANCE ABOUT FISHER CONE BIOPSY EXCISOR FROM FRENCH HOSPITAL 4 FISHER CONE BIOPSY EXCISOR - MEDIUM ARE BROKEN DURING USER". 900-151 FISCHER CONE BIOP EX MED E-COMPLAINT-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11567793 ↗
• MalfunctionMar 22, 2021Break

  BROKE DURING USE. 1216677-2021-00035-1 FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544053 ↗
• MalfunctionMar 22, 2021Break

  BROKE DURING USE. 1216677-2021-00034-1 FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543608 ↗
• MalfunctionAug 23, 2020Thermal Decomposition of Device; Detachment of Device or Device Component

  "THE DOCTOR WAS USING THE BIOPSY FOR CAUTERY AND ONE SIDE OF THE TIP BURNED AND CUTS OFF". 1216677-2020-00189-1 900-151 FISCHER CONE BIOP EX MED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10440637 ↗
• MalfunctionJul 9, 2020Insufficient Device Problem Information

  CUSTOMER STATED: "THE ELECTRODE TIP MELTED WHEN IN USE FOR A LEEP PROCEDURE". 1216677-2020-00143-1 900-151 FISCHER CONE BIOP EX MED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10253486 ↗
• MalfunctionMay 26, 2020Melted; Defective Component

  CUSTOMER STATED: "DEFECTIVE/MELTED END OF ELECTRODE". 900-151 FISCHER CONE BIOP EX MED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10086498 ↗
• MalfunctionFeb 28, 2020Break

  REPORTED BY SERVICE AND REPAIR: "THE WIRES BROKE DURING USE". 900-151 FISCHER CONE BIOP EX MED E-COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770793 ↗
• MalfunctionFeb 20, 2020Break; Thermal Decomposition of Device

  CUSTOMER STATED: "DURING EXCISION BIOPSY, WIRE BROKE AND CHARRED (BLUE) INSULATION ON EXCISOR". 1216677-2020-00055-1 900-151 FISCHER CONE BIOP EX MED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9734374 ↗
• InjuryDec 18, 2019Detachment of Device or Device Component

  PATIENT WAS CONSENTED FOR A LAPAROSCOPIC TUBAL LITIGATION, REMOVAL OF AN IUD AND LEEP OF THE CERVIX. DURING THE LEEP, THE TIPS OF THE LEEP ELECTRODE CAME OFF THE ELECTRODE INTO THE PATIENT¿S UTERUS. A HYSTERECTOMY WAS DONE TO LOCATE THE TIP OF THE ELECTRODE AND IT WAS RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9496499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061651. One submission often covers many models, so check the product and lot details in each record.

• Z-1612-2022 · May 25, 2022 · Open, Classified
  Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
• Z-1879-2018 · Mar 12, 2018 · Terminated
  Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151