Device product
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Z-0113-2016
Product summary
- Event
- Event 72242
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31060
- Official record key
device-enforcement:Z-0113-2016
Official wording
Reason: small puncture marks in a sterile package for an accessory to an Olympus device
Code information: Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536
Distribution pattern: US (nationwide) and Canada.
Derived failure modes
-
Unknown
small puncture marks in a sterile package for an accessory to an Olympus device