Device product
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Z-0389-2017
Product summary
- Event
- Event 75388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0389-2017
Official wording
Reason: Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Code information: Lot No.: 60564713
Distribution pattern: US in the states of MA
Derived failure modes
-
Labeling or packaging
Mislabeled