BiCOAG CD-B620LARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821925039483), received between Apr 9, 2021 and Oct 10, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K123319); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3246-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE 7FR COAX HEMOSTATIC PROBE FAILED OUT OF THE BOX AND CAUSED A SPARK WHEN ATTEMPTING TO BE USED. THE ISSUE OCCURRED DURING THE MIDDLE OF A THERAPEUTIC SMALL BOWEL ENTEROSCOPY WITH HEMOSTASIS AND ABLATION OF LESIONS. THE PATIENT HAD A HISTORY OF GASTROINTESTINAL BLEEDING AND SMALL BOWEL ANGIOECTASIA IDENTIFIED ON CAPSULE ENDOSCOPY. A SECOND GOLD PROBE WAS USED TO CONTROL THE LARGE AVM THAT BEGAN TO BLEED WITH MINIMAL MANIPULATION. NO MEDICAL INTERVENTION WAS REQUIRED AND NO OTHER DEVICES WERE CONNECTED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE TIP BROKE OFF. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904522 ↗
• MalfunctionJun 2, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WHILE HEALING PAPILLA BLEEDING, THE DEVICE (BICOAG PROBE) HEMOSTASIS TIP FELL OFF. ANOTHER BICOAG PROBE WAS OBTAINED, TRIED AND THE SAME ISSUE HAPPENED. BICOAG SETTINGS WERE BISOFTCOAG 40,EFFECT 1. THERE WAS NO PATIENT HARM OR INJURY REPORTED, FULLY COVERED STENT WHERE USED TO HEAL THE BLEEDING . NO USER INJURY REPORTED. THIS EVENT INCLUDES TWO REPORTS ADDRESSING THE TWO DEVICES (BICOAG PROBE) REPORTED IN THE EVENT. REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG PROBE CD-B620LA LOT KR248637 ) . REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG CD-B620LA LOT KR238330 ). THIS REPORT BEING SUBMITTED IS FOR PATIENT IDENTIFIER (B)(6) (BICOAG CD-B620LA LOT KR238330 ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046130 ↗
• MalfunctionJun 2, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WHILE HEALING PAPILLA BLEEDING, THE DEVICE (BICOAG PROBE) HEMOSTASIS TIP FELL OFF. ANOTHER BICOAG PROBE WAS OBTAINED, TRIED AND THE SAME ISSUE HAPPENED. BICOAG SETTINGS WERE BISOFTCOAG 40,EFFECT 1. THERE WAS NO PATIENT HARM OR INJURY REPORTED, FULLY COVERED STENT WHERE USED TO HEAL THE BLEEDING . NO USER INJURY REPORTED. THIS EVENT INCLUDES TWO REPORTS ADDRESSING THE TWO DEVICES (BICOAG PROBE) REPORTED IN THE EVENT. REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG PROBE CD-B620LA LOT KR248637 ) . REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG CD-B620LA LOT KR238330 ). THIS REPORT BEING SUBMITTED IS FOR PATIENT IDENTIFIER (B)(6) (BICOAG PROBE CD-B620LA LOT KR248637 ) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17045863 ↗
• MalfunctionAug 11, 2022Break; Break

  AS REPORTED, TIP OF THE BIPOLAR PROBE BROKE, FELL OFF OUTSIDE PATIENT. ACCORDING TO THE REPORTER, IT WAS USED ONCE, AND WHEN THEY WERE GOING TO USE IT A SECOND TIME THEY REALIZED THE TIP HAD BROKEN OFF OUTSIDE THE PATIENT. CUSTOMER WERE ABLE TO USE A SECOND ITEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210745 ↗
• InjuryMar 23, 2022Energy Output Problem; Energy Output Problem

  THE CUSTOMER INFORMED OLYMPUS, DURING A THERAPEUTIC GASTROSCOPY FOR GASTROINTESTINAL BLEEDING, THE PROBE DID NOT HAVE ANY CURRENT OUTPUT. THREE (3) UNKNOWN CLIPS WERE REQUIRED TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE ESG-100 WAS TESTED 21FEB2022 BY MEDICAL ENGINEERING AND NO ISSUES WERE FOUND. FACILITY TESTED TRAINING PROBE AND NO ISSUES WERE FOUND. THE FACILITY IS COMFORTABLE USING THE PROBE AND ESG-100..

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13869928 ↗
• MalfunctionDec 6, 2021Energy Output Problem; No Device Output; Energy Output Problem; No Device Output

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, WHEN THE DEVICE WAS ACTIVATED, THERE WAS NO OUTPUT. THE USER CONNECTED A SECOND LIKE DEVICE AND THE UNIT WORK NORMALLY. THERE WAS NO PATIENT HARM OR INJURY REPORTED ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12939212 ↗
• MalfunctionApr 9, 2021Break; Break

  THE TIP BROKE OFF WHEN THE CD-B60LA WAS INSERTED INTO THE SCOPE. THE ISSUE OCCURRED IN THE MIDDLE OF A COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER PROBE. THERE WAS NO DELAY IN THE PROCEDURE, AND THE CUSTOMER DID NOT REPORT ANY HEALTH CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123319. One submission often covers many models, so check the product and lot details in each record.

• Z-3244-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
• Z-3247-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
• Z-3245-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
• Z-1481-2024 · Jan 5, 2024 · Open, Classified
  Hemostasis Probe, Model: CD-B622LA