Public recall detail

Olympus Medical Single Use Electrosurgical Knives

2024-03-22

medium
Recall Safety notice
Quick summary

Quick summary: Olympus Medical Single Use Electrosurgical Knives. Date: 2024-03-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Olympus Medical Single Use Electrosurgical Knives. Date: 2024-03-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductOlympus Medical Single Use Electrosurgical Knives
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-75283

Affected products

ProductSingle Use Electrosurgical Knife KD-645
LotAll lots.
ModelKD-645L
Serial numberAll lots.
DescriptionSingle Use Electrosurgical Knife KD-645
ProductSingle Use Electrosurgical Knife - Upper Digestive Tract
LotAll lots.
ModelKD-640L
Serial numberAll lots.
DescriptionSingle Use Electrosurgical Knife - Upper Digestive Tract

Issue

Olympus is initiating a recall to inform customers of an increase in complaints for the triangle tip of the KD-640L and KD-645L triangle tip electrosurgical knives breaking off during use. Olympus' investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. Deterioration, including overheating and burning, may occur due to use with non-Olympus electrosurgical units and/or use of output settings that exceed the specifications.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Recall date2024-03-06
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75283
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare
Source updated2026-01-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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