CONMED DISPOSABLE INSUFFLATION NEEDLE
Received Jan 14, 2005 · Event occurred Jan 1, 2004
Report 1317214-2004-00084 · MDR key 568052
Device
Generic name
Disposable Insufflation Needle
Manufacturer
Conmed Corp.Model number
NACatalog number
60-6050-001
Lot number
NA
Product problems
- Disassembly
- Needle, separation
- Material Separation
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "DURING A LAPAROSCOPY CHOLERCHYSTECTOMY IT WAS NOTED THAT THE NEEDLE WAS SEPARATED IN TWO PARTS DUE TO NON PROPER ADHESION IN THE JOIN OF THE METALLIC NEEDLE WITH THE PLASTIC CONNECTOR."
Additional Manufacturer Narrative
THE QUALITY ENGINEER CONFIRMED THE COMPLAINT. THE RETURNED DEVICE WAS EXAMINED UNDER MAGNIFICATION. IT WAS NOTED THAT THE APPROPRIATE ADHESIVE WAS PRESENT IN THE APPROPRIATE LOCAION. THE DEVICE WAS ALSO CROSS SECTIONED AND THE DIMENSIONS WERE WITHIN SPECIFICATION. WE DO NOT KNOW WHY THE ADHESIVE FAILED TO HOLD. WITHOUT A LOT CODE WE ARE DO NOT KNOW THE MFR DATE OF THE DEVIE, SO WE ARE UNABLE TO DO A DHR REVIEW. THE PRODUCT COMPLAINT DETABASE HAD BEEN SEARCHED AND THERE ARE NO OTHER REPORTS OF SIMILAR EVENTS. WE FEEL THIS WAS A VERY UNUSUAL EVENT. WE CONSIDER THIS INVESTIGATION COMPLETE AND THE COMPLAINT CLOSED.