Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall with a real defect (expired adhesive) creating risk of serious harm including electrical burns to critical structures. No illnesses or injuries have been reported, placing this at the maximum score for risk-of-harm products without reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling the Gyrus Acmi PKS Omni 5mm/33cm surgical instrument (Lot KR121617, 30 units total). This electrosurgical instrument is used for tissue coagulation, grasping, and dissection during laparoscopic and open surgical procedures when used with the Gyrus ACMI G400 workstation. The product was distributed to facilities in California, Georgia, Minnesota, and Tennessee.
The adhesive used as an electrical insulation barrier and secondary retention bond in this instrument has expired and can fail. When the adhesive fails, it could result in a foreign body or biologic reaction within the patient, and/or loss of electrical continuity that could cause tissue burns to critical structures.
Healthcare facilities should immediately identify and remove units matching lot number KR121617 from service. Contact Olympus Corporation of the Americas for return or replacement instructions.
The recalled product
- Product
- Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
- Manufacturer
- Olympus Corporation of the Americas
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 (1)
- Lot number KR121617
Distribution
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