ENDO DISSECT
Received Jun 20, 2018 · Event occurred Jun 5, 2018
Report 2647580-2018-03020 · MDR key 7620613
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7K1584X
Product problems
- Failure to Align
- Failure to Align
Patient
55 YR
- No Patient Involvement
- No Patient Involvement
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, PRE-OPERATIVELY, THE CLAMPS WERE NOT ALIGNED IN THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
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 INDICATES THIS PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. 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.