ENDO DISSECT
Received Mar 27, 2018 · Event occurred Mar 8, 2018
Report 2647580-2018-01558 · MDR key 7374062
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7K1585X
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. 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, LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIPS OR THE JAW OF THE DEVICE WERE NOT ALIGNED PROPERLY. AS IT WAS DIFFICULT TO USE, SURGEON STOPPED USING THE DEVICE AND OPENED ANOTHER ONE TO CONTINUE. THERE WAS NO PATIENT INJURY.