ENDO DISSECT
Received Mar 23, 2018 · Event occurred Mar 6, 2018
Report 2647580-2018-01481 · MDR key 7367087
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7F0157X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. ENGINEERING VERIFIED THAT JAW ALIGNMENT OF DEVICE WAS WITHIN SPECIFICATIONS. ENGINEERING INSPECTED JAWS UNDER A MICROSCOPE AND FOUND NO PHYSICAL DAMAGE TO THE JAWS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL MANUFACTURERS¿ QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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, PRIOR TO OPENING PACKAGE, IT WAS NOTED THAT THE TIPS OF THE DEVICE WERE NOT ALIGNED. THE DEVICE WAS NOT USED INSTEAD A NEW DEVICE WAS OPEN TO COMPLETE THE CASE.