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
Recall
- Recall Number
- Z-1569-2023
- Event Number
- 92079
- Firm
- Aesculap Implant Systems LLC
- FEI Number
- 2916714
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- March 21, 2023
- Posted
- May 5, 2023
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
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
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
Aesculap Inc. issued via Urgent Medical Device Recall Notification Letter via U.S Postal Service, Certified Mail Return Receipt Requested/ USPS Priority Mail on 3/21/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached Product Recall Acknowledgement Form, record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Recall Acknowledgment Form form to the B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Acknowledgement Form, an Aesculap Customer Support representative will contact you to arrange for credit and to have your current inventory returned. Should you identify a problem or safety concern with the product, please report the event promptly by contacting our Postmarket Surveillance Department at 1-833-425-1464.
US Nationwide distribution in the state of OH.
6 pieces