MalfunctionGET
ENDO GRASP
Received Dec 7, 2017 · Event occurred Nov 6, 2017
Report 2647580-2017-08508 · MDR key 7096849
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P5M0122X
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR A LAPAROSCOPIC LOW ANTERIOR RESECTION, UPON OPENING PACKAGE, THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.