DISPOSABLE PAPILLOTOMY KNIFE KD-211Q-0720Recalls & reported problems

Data updated Oct 18, 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 04953170040306), received between Dec 3, 2024 and Dec 3, 2024 — classified as 1 injury.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Aspiration Pneumonitis1
Cholangitis1
Hemorrhage/Blood Loss/Bleeding1
Pancreatitis1
Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿PROPHYLACTIC USE OF A SELF-ASSEMBLING PEPTIDE HYDROGEL FOR PREVENTING DELAYED BLEEDING AFTER ENDOSCOPIC SPHINCTEROTOMY: A PROPENSITY SCORE-MATCHED ANALYSIS." BACKGROUND AND AIM: DELAYED ENDOSCOPIC SPHINCTEROTOMY-RELATED BLEEDING (ES BLEEDING) IS AN UNAVOIDABLE ADVERSE EVENT (AE) THAT CAN HAVE SERIOUS RAMIFICATIONS. INTRAOPERATIVE ES BLEEDING, WHICH STOPS SPONTANEOUSLY IN MOST CASES, IS A KNOWN RISK FACTOR FOR DELAYED BLEEDING. THIS STUDY AIMED TO EXAMINE THE PREVENTIVE EFFECT OF A NOVEL SELF-ASSEMBLING PEPTIDE (SAP) FOR DELAYED ES BLEEDING IN PATIENTS WHO ATTAINED SPONTANEOUS HEMOSTASIS AFTER INTRAOPERATIVE ES BLEEDING. METHODS: A TOTAL OF 1507 PATIENTS MET THE ELIGIBILITY CRITERIA FOR INCLUSION IN THIS STUDY. THE RATES OF DELAYED ES BLEEDING AND AE BESIDES BLEEDING WERE COMPARED BETWEEN PATIENTS ADMINISTERED THE SAP (SAP GROUP) AND THOSE WHO WERE SIMPLY OBSERVED AFTER SPONTANEOUS HEMOSTASIS OF INTRAOPERATIVE ES BLEEDING (CONTROL GROUP). PROPENSITY SCORE MATCHING WAS PERFORMED TO ADJUST FOR DIFFERENCES BETWEEN THE GROUPS. RESULTS: THE RATE OF DELAYED ES BLEEDING WAS SIGNIFICANTLY LOWER IN THE SAP GROUP THAN THAT IN THE CONTROL GROUP
Patient problems: Aspiration Pneumonitis; Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation
MAUDE report 20839451 ↗

Device details

UDI-DI	`04953170040306`
Brand	DISPOSABLE PAPILLOTOMY KNIFE
Model	KD-211Q-0720
Company	Olympus Medical Systems Corp.
Product code	KNS · Unit, electrosurgical, endoscopic (with or without accessories)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Aug 7, 2024

Device type (GMDN): Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

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All Unit, electrosurgical, endoscopic (with or without accessories) devices →

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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