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) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S
Recall
- Recall Number
- Z-2413-2023
- Event Number
- 92579
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- FAS
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- June 8, 2023
- Posted
- August 17, 2023
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
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) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S
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
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 ([email protected]) 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 [email protected]
US Nationwide distribution.
62704 boxes