ENDO DISSECT
Received Apr 19, 2018 · Event occurred Apr 4, 2018
Report 2647580-2018-01928 · MDR key 7443082
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7H1974X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- 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, DURING A DEVICE FOLLOW-UP, THE DEVICE HAD A QUALITY ISSUE AND THE DISSECT CLAMPS ARE NOT LINING UP PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF SIX DEVICES. NO ABNORMALITIES WERE FOUND DURING VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT. JAW ALIGNMENT WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.