Chiba Biopsy Needle with Echogenic Tip MCN2208USRecalls & reported problems
Argon Medical Devices, Inc. · Chiba Biopsy Needle with Echogenic Tip 22ga x 20cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333001873), received between Feb 7, 2026 and Feb 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2026Break
DURING A MAXILLOFACIAL SURGERY PROCEDURE ¿ BILATERAL TMJ ARTHROSCOPY: RIGHT SIDE: WILKES III, AC LEVEL IIIC. SYNOVITIS I, CHONDROMALACIA II, ROOFING 0% TO 100%, CAPSULOTOMY + TOXIN 25 U, DISC REPOSITIONING + DISCOPEXY WITH 1 POSTERO-LATERAL RESORBABLE PIN, BUPIVACAINE + CORTICOSTEROIDS POSTERIOR SUBSYNOVIAL, RADIOFREQUENCY COAGULATION, PRP + HA 3 ML INTRA-ARTICULAR. LEFT SIDE: WILKES II, AC LEVEL IIB. SYNOVITIS II, CHONDROMALACIA II, ROOFING 90%, TOXIN 25 U TO THE PTERYGOID MUSCLE, BUPIVACAINE + CORTICOSTEROIDS POSTERIOR SUBSYNOVIAL, RADIOFREQUENCY COAGULATION, PRP + HA 2 ML INTRA-ARTICULAR. THESE NEEDLES WERE USED IN THE SURGICAL FIELD, AND METALLIC FRAGMENTS WERE OBSERVED TO DETACH DURING NEEDLE WITHDRAWAL, WHICH THEN HAD TO BE REMOVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285885 ↗MalfunctionFeb 7, 2026Break
DURING A MAXILLOFACIAL SURGERY PROCEDURE ¿ BILATERAL TMJ ARTHROSCOPY RIGHT SIDE: WILKES III, AC LEVEL IIIC. SYNOVITIS I, CHONDROMALACIA II, ROOFING 0% TO 100%, CAPSULOTOMY + TOXIN 25 U, DISC REPOSITIONING + DISCOPEXY WITH 1 POSTERO-LATERAL RESORBABLE PIN, BUPIVACAINE + CORTICOSTEROIDS POSTERIOR SUBSYNOVIAL, RADIOFREQUENCY COAGULATION, PRP + HA 3 ML INTRA-ARTICULAR. LEFT SIDE: WILKES II, AC LEVEL IIB. SYNOVITIS II, CHONDROMALACIA II, ROOFING 90%, TOXIN 25 U TO THE PTERYGOID MUSCLE, BUPIVACAINE + CORTICOSTEROIDS POSTERIOR SUBSYNOVIAL, RADIOFREQUENCY COAGULATION, PRP + HA 2 ML INTRA-ARTICULAR. THESE NEEDLES WERE USED IN THE SURGICAL FIELD, AND METALLIC FRAGMENTS WERE OBSERVED TO DETACH DURING NEEDLE WITHDRAWAL, WHICH THEN HAD TO BE REMOVED. THERE ARE 2 MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE FIRST LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285877 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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