Fischer Cone Biopsy ExcisorRecalls & reported problems across all models
Coopersurgical, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Fischer Cone Biopsy Excisor model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 4 models of Fischer Cone Biopsy Excisor by Coopersurgical, Inc. in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2019 and Apr 9, 2024 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Break” (10 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Fischer Cone Biopsy Excisor recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1612-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Fischer Cone Biopsy Excisor problems
Device problems
- Break10
- Melted4
- Detachment of Device or Device Component2
- Flare or Flash2
- Smoking2
- Thermal Decomposition of Device2
- Defective Component1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient2
- Insufficient Information1
- Pain1
Fischer Cone Biopsy Excisor models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fischer Cone Biopsy Excisor 900-157Electrocautery, Gynecologic (And Accessories)1 recall0 reports
- Fischer Cone Biopsy Excisor 900-151Electrocautery, Gynecologic (And Accessories)10 reports
- Fischer Cone Biopsy Excisor 900-152Electrocautery, Gynecologic (And Accessories)6 reports
- Fischer Cone Biopsy Excisor 900-154Electrocautery, Gynecologic (And Accessories)2 reports
Recent Fischer Cone Biopsy Excisor adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionNov 17, 2020Break; Melted
E-COMPLAINT- (B)(4). REPORT STATED - DURING LEEP SURGERY, RUBBER TIP MELTED AND TIP BROKE." FISCHER CONE BIOP EX M EX 900-154 E-COMPLAINT- (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10853589 ↗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 ↗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 ↗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 ↗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 ↗
Other Coopersurgical, Inc. products
All Coopersurgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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