HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme

FDA device recall Z-2413-2023 · posted 2023-08-17 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

Action taken

Olympus issued URGENT: Medical Device Field Corrective Action letter Information on additional Caution in Instructions for Use (IFU) dated June 8, 2023. Letter states reason for recall, health risk and action to take: Carefully read the content of this Field Corrective Action letter. 2. Ensure that all personnel are completely knowledgeable and thoroughly trained on the content of this letter. In particular, observe the instructions of the additional Cautions: Use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects. Do not activate the HF-resection electrode while any portion of the HF-resection electrode tip is in contact with another metal object. This can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip. If excessive heating or physical forces cause damage to the HF-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal. In some electrode models a second additional Caution has been added: Contact between the HF-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the HF-resection electrode and the metal part. Always keep a distance of at least 10 mm between the HF-resection electrode and metal parts 3. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email (Olympus7544@sedgwick.com) or Fax (888-345-4628). For any questions about the acknowledgement form, please call the Sedgwick team at 888-843-0252. If you have further distributed this product, identify your customers and forward them this letter. Please appropriately document your notification process and let us know the end-customer feedback accordingly. If you have any questions or concerns, please do not hesitate to contact me directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com

Root cause

Process design

Status

Open, Classified

Product code

FAS

Quantity affected

62704 boxes

Distribution

US Nationwide distribution.

Date initiated

2023-06-08

Date posted

2023-08-17

Location

Center Valley, PA

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