BIOPSYBELL DISKOMRecalls & reported problems
Biopsybell Srl · DISC DECOMPRESSION NEEDLE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033860019747), received between Apr 3, 2024 and Apr 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON 04MAR2024 OUR US DISTRIBUTOR SOLUTION MEDICAL IN THE PERSON OF (B)(6) NOTIFIED OUR CUSTOMER CARE ABOUT THE SIGNALATION. ON 06MAR2024 AFTER FIRST REQUEST FOR DETAIL BY QUALITY WE RECEIVED THE FOLLOWING INFORMATION: A BRIEF DESCRIPTION RELEASED BY SURGICAL CENTRE: CERVICAL PERCUTANEOUS DISCECTOMY. ¾ INCH OF THE WIRE BROKE OFF IN PATIENT. PATIENT THEN TRANSPORTED TO HOSPITAL TO HAVE PIECE REMOVED. PHYSICIAN RAN THE DISKOM DEVICE FOR 5 MINUTES INSTEAD OF 2 MINUTES IN A BACK-AND-FORTH MOTION PATIENT NAME - INITIALS: (B)(6) - AGE OF PATIENT / BIRTH DATE: (B)(6) 1988 - MALE - 190LBS AND FURTHER INFORMATION BELOW: 1. CERVICAL PERCUTANEOUS DISCECTOMY PERFORMED IN C5-C6 2. ABOUT ¾ INCH OF THE PROBE WIRE BRAKE. THE MOMENT IT HAPPENED IS UNKNOWN, THE PHYSICIAN SAID SHE REALIZED IT WHEN SHE NOTICED THE PIECE OF WIRE IN THE PATIENT ON THE X RAY IMAGE 3. PICTURE AVAILABLE. THE PATIENT WAS TRANSPORTED TO HOSPITAL. HAD SURGERY TO REMOVE THE WIRE. THE PHYSICIAN ON MONDAY (B)(6) 2024 SAID THE PATIENT WAS AT HOME DOING FINE. 4. THE SURGERY CENTER ACCIDENTLY THREW OUT THE STICKER WITH THE SERIAL #. ALL THAT IS KNOWN IS THE LOT # ( 2401114). 5. THERE HAVE BEEN NO OTHER ISSUES ASSOCIATED WITH THIS LOT
Patient problems: Spinal Column Injury
MAUDE report 19032655 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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