Fischer Cone Biopsy Excisor 900-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888937003727), received between Apr 9, 2020 and Apr 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Break; Break

  PRODUCTS HAVE BROKEN WIRE. INCIDENT OCCURRED DURING USE, WITH NO PATIENT INJURY BUT MEDICAL/PROCEDURAL INTERVENTION PERFORMED. 1216677-2021-00232 FISCHER CONE BIOP EX LG 900-152 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075037 ↗
• MalfunctionMay 21, 2021Material Separation

  A LOOP ELECTRODE EXCISIONAL PROCEDURE CERVIX CONE BIOPSY FOR A HIGH GRADE CERVICAL DYSPLASIA WAS PERFORMED IN WINTER 2021, THERE WAS NO NOTABLE SIDE EFFECTS FROM THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT EXPERIENCED PAIN FOLLOWING THE SURGERY AND 16 DAYS LATER EXPELLED A PIECE OF DEVICE FROM HER VAGINA, SHE VISITED THE ER THAT DAY AND STAFF ATTENDED TO HER CARE. SHE CONTINUED TO BE A GREAT DEAL OF PAIN AND RETURNED TO THE ER 2 DAYS LATER FOR ADDITIONAL CARE. THE PIECE OF DEVICE WAS IDENTIFIED TO BE PART OF THE FISHER CONE BIOPSY OF UNKNOWN SIZE. DURING THE LOOP ELECTRODE EXCISIONAL PROCEDURE TWO DIFFERENT SIZES WERE USED. FISCHER CONE BIOP EX LG 900-152 E-COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 11865500 ↗
• MalfunctionOct 21, 2020Material Split, Cut or Torn

  (B)(4). REPORT SUBMITTED BY DISTRIBUTOR ON BEHALF OF END-USER- INCIDENT -WIRE SNAPPING AT TIP OF INSTRUMENT (HAPPENED WITH X 6 ELECTRODES), ALSO HAPPENED DURING A CASE EARLIER THIS MONTH. I HAVE BEEN TOLD THAT THE PRODUCT WAS THROWN OUT. FISCHER CONE BIOP EX LG 900-152 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10710327 ↗
• MalfunctionOct 16, 2020Break

  REPORTED BY DISTRIBUTOR ON BEHALF OF END-USER- "WE HAVE HAD A RUN OF FISCHER CONE ELECTRODES WHICH HAVE BROKEN DURING LLETZ CASES. THIS HAS RESULTED IN NUMEROUS ELECTRODES BEING USED PER CASE". 1216677-2020-00224-1 900-152 FISCHER CONE BIOP EX LG (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10691342 ↗
• MalfunctionMay 14, 2020Melted; Smoking; Flare or Flash

  WHEN MD FIRST ENGAGED ELECTRODE, THERE WAS A FLASH, ASSUMED TISSUE, REMOVED AND SAW PLASTIC MELTED AND SMOKING. NO ISSUES WITH PATIENT, USED ANOTHER WITH SAME LOT - WORKED OK AND FINISHED CASE. 1216677-2020-00119-1 FISCHER CONE BIOP EX LG 900-152 E-COMPLAINT-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10058324 ↗
• MalfunctionApr 9, 2020Melted; Smoking; Flare or Flash

  WHEN MD FIRST ENGAGED ELECTRODE, THERE WAS A FLASH, ASSUMED TISSUE, REMOVED AND SAW PLASTIC MELTED AND SMOKING. NO ISSUES WITH PATIENT - USED ANOTHER WITH SAME LOT - WORKED OK AND FINISHED CASE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948196 ↗

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