ENDO DISSECT
Received Jun 7, 2017 · Event occurred Apr 25, 2017
Report 2647580-2017-05538 · MDR key 6618413
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6L0359X
Product problems
- Failure to Align
- Failure to Align
Patient
72 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 LAP CHOLECYSTECTOMY PROCEDURE, THE DEVICE TIPS WERE MALFORMED AND NOT MEETING FLUSH. TO COMPLETE THE PROCEDURE THEY USED ANOTHER DEVICE. NO PATIENT INJURY HAS BEEN NOTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.