UNKNOWN CLIPGUN
Received Nov 6, 2014
Report 2021898-2014-00439 · MDR key 4233548
Device
Generic name
Hemostat, Surgical
Manufacturer
Medtronic NeurosurgeryCatalog number
UNKNOWN-G
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4)
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A CLIP WAS INADVERTANTLY LEFT IN THE PATIENT. IT WAS INCIDENTALLY DISCOVERED IN A SUBSEQUENT OPERATION AT ANOTHER HOSPITAL. IT WAS ALSO REPORTED THAT THERE WAS NO HARM TO THE PATIENT.