ENDO DISSECT
Received May 2, 2017 · Event occurred Apr 25, 2017
Report 2647580-2017-05376 · MDR key 6536563
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6L0359X
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE THE TIPS OF THE DEVICE FROM THE LOT WERE NOT MEETING FLUSH WHEN THE JAWS WERE CLOSED. THERE IS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Description of Event or Problem
ACCORDING TO THE REPORTER, PER ADDITIONAL INFORMATION RECEIVED PRIOR TO THE PROCEDURE FOR A LAP CHOLECYSTECTOMY, THE TIPS OF THE DEVICE FROM THE LOT WERE NOT MEETING FLUSH WHEN THE JAWS WERE CLOSED. TO RESOLVE THE ISSUE, THEY UTILIZED THE NON DISPOSABLE ENDO DISSECTORS FROM THEIR TRAY. DEVICE WAS NOT USED ON PATIENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.