ENDO GRASP
Received Feb 20, 2018 · Event occurred Dec 20, 2017
Report 2647580-2018-00872 · MDR key 7283907
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P6L0090X
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CORRECTION POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. ENGINEERING FOUND NO ABNORMALITIES DURING FUNCTIONAL TESTING. ENGINEERING INSPECTED THE SPREAD DISTANCE BETWEEN THE JAWS AND FOUND THEM TO BE ACCEPTABLE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MANUFACTURER'S QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. 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, OCCURRED PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. UPON OPENING THE PACKAGE, TRIED TO OPEN AND C LOSE THE DEVICE. BUT IT WOULD NOT OPEN COMPLETELY. THE DEVICE WAS NOT USED ON A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.