ENDO GRASP
Received Mar 7, 2017 · Event occurred Feb 7, 2017
Report 2647580-2017-05053 · MDR key 6383350
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P5J0386X
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) RECEIVED ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE SHEATH WAS DAMAGED PROXIMAL TO THE JAWS. PMV PERFORMED FUNCTIONAL TESTING WHICH INCLUDED : DEVICE ARTICULATED, ROTATED AND EXTENDED AND RETRACTED WITHOUT DIFFICULTY. THE JAWS OPENED AND CLOSED AND GRASPED MEDIA WITHOUT DIFFICULTY. 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 USE ON THE PATIENT. THE FRONT PLASTIC PART OF THE DEVICE IS DAMAGED WHEN IT IS OPENED.