ENDO DISSECT* 5MM INSTRUMENT
Received Jan 30, 2017
Report 2647580-2017-00106 · MDR key 6287249
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Covidien, Formerly Ussc Puerto Rico IncModel number
176645Catalog number
176645
Lot number
P5K0836X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). POST MARKET VIGILANCE (PMV) CONCURRENTLY WITH ENGINEERING LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THE VISUAL INSPECTION OF THE DEVICE NOTED NO VISUAL ABNORMALITIES. THE ROTATION KNOB FUNCTIONED PROPERLY, AND THE JAWS OPENED AND CLOSED GRASPING TEST MEDIA WITHOUT DIFFICULTY. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT MET RELEASE SPECIFICATIONS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO A LAP CHOLE PROCEDURE, A BOX OF DEFECTIVE DEVICES WAS FOUND. THE JAWS ARE MANUFACTURED MISALIGNED AND DO NOT MEET. THERE WAS NO PATIENT OR USER INJURY OR HAZARD. THE DEVICES WERE NOT USED ON THE PATIENT. NEW DEVICES WERE OPENED TO CONTINUE THE PROCEDURE.