UNKNOWN CLIPGUN
Received Nov 6, 2014 · Event occurred Aug 7, 2014
Report 2021898-2014-00440 · MDR key 4233592
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 INADVERTENTLY LEFT IN A PATIENT. THE PATIENT WAS INITIALLY OPERATED ON (B)(6) 2014. FOR UNRELATED REASONS TO THE CLIP, SHE WAS REOPERATED ON (B)(6) 2014. THE CLIP WAS DISCOVERED TO BE LEFT IN THE PATIENT DURING THE SECOND OPERATION. IT WAS ALSO REPORTED THAT THERE WAS NO HARM TO THE PATIENT.