ENDO DISSECT
Received Dec 1, 2017 · Event occurred Nov 3, 2017
Report 2647580-2017-08142 · MDR key 7077488
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6M0236X
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
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. NO ABNORMALITIES WERE FOUND DURING VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE JAWS OF THE PRODUCT WERE NOT SMOOTH AND WERE NOT CLOSING COMPLETELY. THE DEVICE WAS REPLACED WITH NEW ONE TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.