BiCOAG CD-B622LARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00821925039452), received between Jan 12, 2021 and Jun 10, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

3 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-3247-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Jan 5, 2024Open, Classified

   The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

   Z-1481-2024 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING THERAPEUTIC HEMOSTASIS FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR A PAPILLOTOMY BLEED, THE 7FR FIXEDPIN HEMOSTATIC PROBE DETACHED AND FELL INTO THE SECOND PORTION OF THE DUODENUM, RESULTING IN A DELAY OF AROUND 30 MINUTES. THE PROBE TIP MEASURED 2 MM BY 6 MM. THE DEVICE COULD NOT BE LOCATED ENDOSCOPICALLY WITHIN THE PATIENT'S DUODENAL LUMEN AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE FROM ANOTHER COMPANY. AN X-RAY WAS PERFORMED ON THE SAME DAY, REVEALING THAT THE SUBJECT DEVICE HAD MIGRATED INTO THE JEJUNUM. IT HAS BEEN REPORTED THAT THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22180380 ↗
• InjuryOct 10, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE HEMOSTATIC PROBE TIP "BURNED OFF" DURING A DIAGNOSTIC COLONOSCOPY AND FELL INTO THE PATIENT'S COLON. THE DOCTOR RETRIEVED THE BROKEN TIP FROM THE COLON. THE PROCEDURE WAS EXTENDED MOMENTARILY AND ANOTHER PIECE OF EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE ISSUE DID NOT AFFECT THE DIAGNOSTIC OUTCOME OF THE PATIENT AND NO FURTHER INTERVENTION WAS NEEDED. THE PATIENT WAS REPORTED TO BE "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417633 ↗
• MalfunctionAug 21, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THE HEMOSTATIC PROBE DID NOT GENERATE ANY ENERGY AFTER BEING CONNECTED TO THE DIATHERMY. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010347 ↗
• MalfunctionJun 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THE SUBJECT DEVICE WAS EASILY STICKING TO THE TISSUE. THE EVENT WAS IDENTIFIED DURING A THERAPEUTIC GASTROINTESTINAL BLEEDING PROCEDURE, AND IT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623146 ↗
• MalfunctionJun 26, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE CERAMIC TIP OF BIOCOAG PROBE WAS EASY TO STICK TO THE TISSUE/WOUND. THE ISSUE WAS FOUND DURING A THERAPEUTIC GASTRO INTESTINAL (GI) BLEEDING IN THE MIDDLE OF A PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613205 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588529 ↗
• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS BICOAG HEMOSTASIS PROBE HAD A DETACHED TIP. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE FOR HEMOSTASIS OF A GASTROINTESTINAL BLEED OF THE DUODENUM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436342 ↗
• MalfunctionAug 30, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT AFTER THE PROBE WAS REMOVED FROM THE SCOPE, THE NURSE USED GAUZE TO CLEAN THE TIP, THE TIP FELL OFF ON THE TROLLEY OF THE 7FR FIXEDPIN HEMOSTATIC PROBE. THE REPORTED ISSUE OCCURRED AT THE END OF THE THERAPEUTIC SAMPLING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY OR PATIENT HARM, OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656614 ↗
• MalfunctionJun 12, 2023Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS USED FOR A PROCEDURE (AN UNSPECIFIED), AFTER USE, THE NURSE HELPED TO TAKE IT OUT FROM THE SCOPE AND THE CERAMIC TIP FELL OFF ON THE TROLLEY WHEN THE NURSE WAS GENTLY CLEANING THE TIP. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17103896 ↗
• MalfunctionNov 20, 2022Failure to Deliver Energy; Output Problem; Failure to Deliver Energy; Output Problem

  IT WAS REPORTED "THE ACCESSORY (CD-B622LA) SERIAL # (B)(4) AND SERIAL # (B)(4) WAS PLACED, ONE OF EACH SERIAL NUMBER, AND THE BIPOLAR PART OF THE ESG-100 IN SOFT COAG 30 BUT IT DID NOT BURN. ACCORDING TO THE REPORTER, THE SERIAL # (B)(4) WAS REPLACED BY ANOTHER SERIAL # (B)(4) . ACCORDING TO THE REPORT, THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE, NOTED THE INTENDED PROCEDURE WAS NOT COMPLETED, HOWEVER, THE REPORT NOTED , THE ISSUE WAS NOTICED AFTER PROCEDURE ( THERAPEUTIC ESG ENDOSCOPY). A FOLLOW UP IS IN PROGRESS TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) SERIAL # (B)(4). REPORT WITH PATIENT IDENTIFIER (B)(6) SERIAL # (B)(4). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6), SERIAL # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831894 ↗
• MalfunctionNov 20, 2022Failure to Deliver Energy; Output Problem; Failure to Deliver Energy; Output Problem

  IT WAS REPORTED "THE ACCESSORY (CD-B622LA) SERIAL #(B)(4) AND SERIAL # (B)(4) WAS PLACED, ONE OF EACH SERIAL NUMBER, AND THE BIPOLAR PART OF THE ESG-100 IN SOFT COAG 30 BUT IT DID NOT BURN. ACCORDING TO THE REPORTER, THE SERIAL #(B)(4) WAS REPLACED BY ANOTHER SERIAL # (B)(4) . ACCORDING TO THE REPORT, THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE, NOTED THE INTENDED PROCEDURE WAS NOT COMPLETED, HOWEVER, THE REPORT NOTED , THE ISSUE WAS NOTICED AFTER PROCEDURE ( THERAPEUTIC ESG ENDOSCOPY). A FOLLOW UP IS IN PROGRESS TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) SERIAL #(B)(4). REPORT WITH PATIENT IDENTIFIER (B)(6), SERIAL # (B)(4). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) ( CD-B622LA SERIAL #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831838 ↗
• MalfunctionJun 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE GI PHYSICIAN USED THE BICOAG HEMOSTASIS PROBE FOR GI BLEEDING IN DUODENAL ON (B)(6) 2022. DURING PROCEDURE (THERAPEUTIC), THE DOCTOR DISCOVERED THE TIP OF PROBE WAS DETACHED FROM ITS BODY. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793757 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  IT WAS REPORTED BY THE CUSTOMER, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE USING A 7FR FIXEDPIN HEMOSTATIC PROBE, THE TIP OF THE PROBE FIRST SPARKED, THEN BROKE OFF AND REMAINED IN THE PATIENTS STOMACH AFTER THE PROCEDURE. EVENTS AS FOLLOWS: THE PATIENT WAS ADMITTED TO THE FACILITY FROM AN OUTSIDE HOSPITAL AFTER PRESENTING WITH MELENA. THE PATIENT HAD A HISTORY OF NON-STEROIDAL ANTI INFLAMMATORY (NSAID) USE AND A HISTORY OF IRON DEFICIENCY ANEMIA FOR WHICH HE INITIALLY UNDERWENT EGD/COLONOSCOPY IN 2014 WITH NON-BLEEDING DIVERTICULI NOTED DURING THE COLONOSCOPY, AND THE EGD SHOWING LINEAR EROSIONS AROUND HIATAL HERNIA. THE LAST EGD WAS PERFORMED IN 2016 AND WAS NORMAL WITH THE EXCEPTION OF A LARGE HIATAL HERNIA. THE PATIENT'S HEMOGLOBIN ON ADMISSION WAS 5MG/DL. THE PATIENT WAS GIVEN 3 UNITS OF BLOOD. THREE DAYS AFTER ADMISSION THE PATIENT WAS STABLE WITH NO FURTHER EVIDENCE OF BLEEDING. AN EGD WAS COMPLETED ON DAY 3 AFTER ADMISSION WITH THE FOLLOWING FINDINGS: STOMACH: 5CM HIATAL HERNIA. 1.5CM CRATERED GASTRIC ULCER SEEN WITH VISIBLE VESSEL AT LESSER CURVATURE JUST BELOW HIATAL HERNIA, FOREST CLASS 1B. ULCER WAS NOT BLEEDING INITIALLY. VISIBLE VESSEL TREATED WITH EPINEPHR

  Patient problems: Foreign Body In Patient

  MAUDE report 12478785 ↗
• MalfunctionJun 24, 2021Defective Device; Output Problem; Defective Device; Output Problem

  IT WAS REPORTED THAT THE DEVICE PROBE DID NOT WORKED. THE PROBE STOPPED FUNCTIONING. THE ISSUE OCCURRED DURING AN UPPER ENDOSCOPY PROCEDURE. THE DEFECTIVE PROBE WAS REPLACED WITH ANOTHER PROBE. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM OR INJURY TO THE PATIENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063893 ↗
• MalfunctionMar 26, 2021No Device Output; No Device Output

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE BICOAGULATION PROBE DID NOT WORK AT ALL TO COAGULATE A GI BLEED ON THE PATIENT. THE USER OPENED ANOTHER PROBE TO COAGULATE THE GI BLEED IN THE PATIENT. THE LOT NUMBER USED WAS NOT PROVIDED. THE REPORTER STATED THAT THE EVENT DID NOT DELAY THE PROCEDURE MUCH. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574606 ↗
• MalfunctionJan 12, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS FOUND NOT WORKING, THE PROBE FAILED TO WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11154851 ↗

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-3245-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
• Z-3244-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
• Z-3246-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.