ENDO GRASP
Received Oct 12, 2017 · Event occurred Sep 7, 2017
Report 2647580-2017-07158 · MDR key 6945849
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
174233Catalog number
174233
Lot number
P6L0090X
Product problems
- Break
- Difficult to Open or Close
- Break
- 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
POST MARKET VIGILANCE (PMV) RECEIVED ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED NO ABNORMALITIES.PMV PERFORMED FUNCTIONAL TESTING WHICH INCLUDED THE FOLLOWING: THE ROTATION KNOB FUNCTIONED WITHOUT DIFFICULTY. THE JAWS EXTENDED AND RETRACTED WITHOUT DIFFICULTY. THE JAWS WERE OPENED, CLOSED, AND APPLIED TO TEST MEDIA AND GRASPED THE MEDIA WITHOUT ISSUE. ADDITIONAL INFORMATION : IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING USE ON THE PATIENT, THE JAWS WOULD NOT OPEN PROPERLY. WHEN THE DEVICE WAS ARTICULATED, THE JAWS COULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.