MalfunctionJOS
LEVEEN SUPERSLIM NEEDLE ELECTRODE
Received May 27, 2009
Report 3005099803-2009-02114 · MDR key 1393513
Device
Generic name
Electrode, Electrosurgical
Manufacturer
Boston Scientific Corporation-spencerModel number
M001262260Catalog number
26-226
Lot number
11303965
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
UPON INSPECTION OF THE DEVICE BY A QUALITY ASSURANCE (QA) PERSONNEL, A HAIR WAS FOUND INSIDE THE SEALED PACKAGE. NOTE: THERE IS NO PATIENT INVOLVED AS THIS DEVICE WAS RETURNED TO THE DISTRIBUTION CENTER DUE TO A PRODUCT RECALL.
Additional Manufacturer Narrative
FOREIGN MATTER FOUND INSIDE SEALED PACKAGE THE DEVICE HAS NOT BEEN EVALUATED, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THE EVENT
Remedial action
- Recall