ENDO DISSECT
Received Aug 14, 2018 · Event occurred Jun 5, 2018
Report 2647580-2018-04030 · MDR key 7780858
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Product problems
- Failure to Align
- Failure to Align
Patient
55 YR
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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, PRE-OPERATIVELY OF HEMICOLECTOMY, THE JAWS WERE NOT ALIGNED IN THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
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, PRE-OPERATIVELY, THE JAWS WERE NOT ALIGNED IN THE TIP. THERE WAS NO PATIENT INVOLVEMENT.