MalfunctionGET
ENDO DISSECT
Received May 10, 2018 · Event occurred May 1, 2018
Report 2647580-2018-02406 · MDR key 7502604
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P8A0576X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence 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 PRIOR TO THE PROCEDURE, BEFORE THE OPENING PACKAGE, NURSE NOTED THAT THE JAWS WERE NOT ALIGNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.