ENDO GRASP
Received Apr 28, 2017 · Event occurred Nov 29, 2016
Report 2647580-2017-05357 · MDR key 6530939
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P5L0568X
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
AFTER START USING THE PRODUCT, THE USER ROTICURATE THE DEVICE IN PATIENT CAVITY, THEN THE CLEAR COVER AT BETWEEN JAWS AND SHAFT PEELED AND FELL OUT. THE FALLEN FRAGMENT WAS RETRIEVED FROM PATIENT CAVITY. NEW PRODUCT WAS OPENED TO CONTINUE THE PROCEDURE. PROCEDURE: LAPAROSCOPIC SURGERY FOR PROSTATE CANCER. UDI NUMBER IS NOT AVAILABLE. THE EVENT OCCURRED IN USE FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS NOT EXTENDED. THE STATUS OF THE PATIENT: NO PROBLEM. ADDITIONAL TISSUE RESECTION IS NOT REQUIRED. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. NO BLEEDING OCCURRED. MALE PATIENT. THE PATIENT AGE IS NOT AVAILABLE. THE PATIENT WEIGHT IS NOT AVAILABLE. THE DEVICE WAS NOT REPROCESSED/RE-STERILIZED PRIOR TO USE.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.