Device product
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Z-0159-2013
Product summary
- Event
- Event 62386
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 boxes
- Official record key
device-enforcement:Z-0159-2013
Official wording
Reason: The tip of the product could come loose or unravel.
Code information: Lot 1104-01
Distribution pattern: US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.
Derived failure modes
-
Unknown
The tip of the product could come loose or unravel.