Recall Z-2413-2023 ยท FAS Electrode, Electrosurgical, Active, Urological
Olympus Corporation of the Americas
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22
| Date | Aug 17, 2023 (initiated Jun 8, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process design |
| Action | 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 |
| Quantity | 62704 boxes |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS Olympus Winter & Ibe GmbH, Jul 1, 2010 |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS Olympus Winter & Ibe GmbH, Jan 11, 2011 |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES Olympus Winter & Ibe GmbH, Jun 20, 2012 |
| K152092 | Resection Electrodes Olympus Winter & Ibe GmbH, Oct 26, 2015 |