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HF Resection Electrodes - HF resection electrodes are part… recallZ-2413-2023 · Olympus Corporation of the Americas · initiated Jun 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

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]

Recall details

Recall number
Z-2413-2023
Status
Open, Classified
Initiated by the company
Jun 8, 2023
Posted by the FDA
Aug 17, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
62704 boxes
Product code
FAS
FDA submissions
K100275, K152092, K102781, K120418
Distribution
US Nationwide distribution.

Product 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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

# Model UDI(DI) 1) A22201C 14042761036648 2) A22201D 14042761036655 3) A22202C 14042761036662 4) A22203C 14042761036686 5) A22205C 14042761036709 6) A22205D 14042761036716 7) A22206C 14042761036723 8) A22207C 14042761036747 9) A22211C 14042761036761 10) A22221C 14042761029466 11) A22222C 14042761030431 12) A22223C 14042761029770 13) A22231C 14042761036778 14) A22231D 14042761036785 15) A22251C 14042761036815 16) A22253C 14042761036822 17) A22255C 14042761036839 18) A22257C 14042761030448 19) A22258C 14042761036853 20) A22266C 14042761036891 21) A44728C 14042761039090 22) WA22037C 14042761051566 23) WA22038C 14042761051580 24) WA22039C 14042761051603 25) WA22301D 14042761051658 26) WA22301S 14042761082386 27) WA22302D 14042761051665 28) WA22305D 14042761051672 29) WA22305S 14042761082393 30) WA22306D 14042761051689 31) WA22332D 14042761051702 32) WA22351C 14042761051719 33) WA22355C 14042761051719 34) WA22503D 14042761068205 35) WA22507D 14042761068236 36) WA22521C 14042761068243 37) WA22523C 14042761068267 38) WA22537D 14042761073940 39) WA22538C 14042761073964 40) WA22539D 14042761073971 41) WA22540S 14042761083710 42) WA22541S 14042761083727 43) WA22542S 14042761083734 44) WA22544S 14042761083758 45) WA22557C 14042761068342 46) WA22566S 14042761083765 47) WA22602D 14042761075456 48) WA22603D 14042761075463 49) WA22606D 14042761075470 50) WA22607D 14042761075487 51) WA22621C 14042761075494 52) WA22623C 14042761075500 53) WA22632D 14042761075517 54) WA22651C 14042761075524 55) WA22655C 14042761075531 56) WA22657C 14042761075548 57) WA47505S 14042761085035 58) WA47506S 14042761085042 59) WA47507S 14042761085073 60) WA47540S 14042761085103 61) WA47551S 14042761085059 62) WA47555S 14042761085066 63) WA47560S 14042761085080 64) WA47566S 14042761085097 All lot numbers

Devices named in this recall

63 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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