DISPOSABLE HOT BIOPSY FORCEPS FD-210URecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170158759), received between Aug 12, 2019 and Jan 3, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNDERWATER ENDOSCOPIC SUBMUCOSAL DISSECTION AND HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION AS RESCUE THERAPY IN DIFFICULT COLORECTAL CASES". THIS RETROSPECTIVE ANALYSIS DEMONSTRATES THAT UNDERWATER ESD (U-ESD) AND HYBRID ESD (H-ESD) ARE BOTH EFFECTIVE AND SAFE AS RESCUE THERAPY IN DIFFICULT COLORECTAL ESD. THERE WERE FIFTY-NINE COLORECTAL NEOPLASMS WERE CONSIDERED, 22 OF WHICH WERE REMOVED BY U-ESD AND 37 BY H-ESD. THE EN BLOC RESECTION RATE IN THE U-ESD GROUP WAS 100 %, WHILE IT WAS 59.5% IN THE H-ESD GROUP. DISSECTION SPEED WAS 17.7MM2/MIN IN THE U-ESD GROUP AND 8.3MM2/MIN IN THE H-ESD GROUP. THIS STUDY CONCLUDES THAT THE U-ESD AND H-ESD ARE BOTH EFFECTIVE AND SAFE TECHNIQUES IN DIFFICULT COLORECTAL SITUATIONS. U-ESD IS PARTICULARLY EFFECTIVE AND FAST FOR LARGE LESIONS WHEN IT IS NOT POSSIBLE TO OBTAIN COMFORTABLE KNIFE POSITION, WHILE H-ESD IS MORE SUITABLE FOR VERY FIBROTIC LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ [UNDERWATER ESD] BACTEREMIA - 1 PATIENT [HYBRID ESD] PERFORATION - 4 PATIENTS BLEEDING - 4 PATIENTS BACTEREMIA - 1 PATIENT THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLL

  Patient problems: Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16090495 ↗
• InjuryAug 12, 2019Output Problem

  THE SERVICE CENTER WAS INFORMED THAT THE DURING THE PROCEDURE TWO DEVICES OF THE SAME LOT DID NOT WORK PROPERLY. THE DEVICE CONTACT WAS REPORTED TO BE INTERMITTENT WHICH CAUSED A DELAY OF TREATMENT RESULTING IN EXCESSIVE BLEEDING. A CLIP WAS USED TO CONTROL THE BLEEDING AND COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT IS FOR DEVICE 2 OF 2.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8884631 ↗
• InjuryAug 12, 2019Use of Device Problem; Use of Device Problem

  THE SERVICE CENTER WAS INFORMED THAT THE DURING THE PROCEDURE TWO DEVICES OF THE SAME LOT DID NOT WORK PROPERLY. THE DEVICE CONTACT WAS REPORTED TO BE INTERMITTENT WHICH CAUSED A DELAY OF TREATMENT RESULTING IN EXCESSIVE BLEEDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT IS FOR DEVICE 2 OF 2.

  Patient problems: Blood Loss

  MAUDE report 8884587 ↗
• InjuryAug 12, 2019Therapeutic or Diagnostic Output Failure

  THE SERVICE CENTER WAS INFORMED THAT THE DURING THE PROCEDURE TWO DEVICES OF THE SAME LOT DID NOT WORK PROPERLY. THE DEVICE CONTACT WAS REPORTED TO BE INTERMITTENT WHICH CAUSED A DELAY OF TREATMENT RESULTING IN EXCESSIVE BLEEDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8884563 ↗
• InjuryAug 12, 2019Use of Device Problem; Use of Device Problem

  THE SERVICE CENTER WAS INFORMED THAT THE DURING THE PROCEDURE TWO DEVICES OF THE SAME LOT DID NOT WORK PROPERLY. THE DEVICE CONTACT WAS REPORTED TO BE INTERMITTENT. THE DEVICE MALFUNCTION WAS REPORTED TO HAVE CAUSED A DELAY OF TREATMENT RESULTING IN EXCESSIVE BLEEDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT IS FOR DEVICE 1 OF 2.

  Patient problems: Blood Loss

  MAUDE report 8884486 ↗