ENDO DISSECT
Received Apr 13, 2018 · Event occurred Mar 20, 2018
Report 2647580-2018-01823 · MDR key 7429329
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7H1974X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF SIX DEVICES. ENGINEERING VERIFIED THAT JAW ALIGNMENT OF DEVICES WAS WITHIN SPECIFICATIONS. ENGINEERING INSPECTED JAWS UNDER A MICROSCOPE AND FOUND NO PHYSICAL DAMAGE TO ANY OF THE JAWS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE TIP OF THE DISSECTOR WAS NOT ALIGNING CORRECTLY. PRODUCT NOT UP TO STANDARD. THERE WAS NO PATIENT INVOLVEMENT.