Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring
Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.
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: FDA Class II recall of a surgical device with potential for foreign body retention (loose spring that may fall out during procedure). No injuries or hospitalizations reported; the hazard is currently theoretical but represents significant risk if the spring is released during surgery.
Plain-English summary
Aesculap Implant Systems LLC is recalling the Aesculap Caiman Articulating D5/360MM, an electrosurgical cutting and coagulation device used for cutting, coagulation, and ablation during endoscopic and open surgical procedures. The devices are being recalled because a spring may become loose and fall out during use. If the spring falls out during a surgical procedure, it could potentially enter the patient's body.
The affected units have Lot Number 52785146 (UDI-DI: 04046964837340). Six units were distributed nationwide in the state of Ohio.
If you have or use one of these devices, you should contact Aesculap Implant Systems LLC or the U.S. Food and Drug Administration for information about the recall and appropriate actions.
The recalled product
- Product
- Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device
- Hazard
- foreign-body
- device-malfunction
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)
- UDI-DI: 04046964837340 Lot Number: 52785146
Distribution
Distributed nationwide across the United States.
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