MalfunctionGET
ENDO GRASP
Received Nov 1, 2017 · Event occurred Oct 9, 2017
Report 2647580-2017-07528 · MDR key 6994281
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P6L0089X
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
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, DURING A LAPAROSCOPIC COLECTOMY, WHEN THE SURGEON RETICULATED THE DEVICE, HE/SHE NOTICED THAT "PLASTIC WAS OFF INSIDE OF THE PRODUCT." THE PRODUCT WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.