Olympus PKS cutting forceps 3005PK jaws may break from defective welds
Olympus is recalling PKS Cutting Forceps model 3005PK because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break during clinical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the jaw may break inside a patient during a procedure, and no injuries are stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus PKS Cutting Forceps, 5 mm 33 cm, model 3005PK. The forceps are passed through a 5 mm cannula, achieving coagulation using electrosurgical energy under visualisation, and are intended for use with the PKS electrical generator. About 93 units were distributed nationwide in the United States and to Canada, Mexico, the EU, Australia, China, Singapore, Korea and Japan. The FDA has classified this recall as Class II.
Olympus identified that the cutting forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the forceps' jaw breaking during clinical use.
All unexpired lot numbers are affected. The device carries UDI 00821925036000.
Facilities can identify affected forceps by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: 3005PK
- UDI: 00821925036000
- Lot Numbers: All unexpired
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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