ENDO DISSECT
Received Apr 16, 2018
Report 2647580-2018-01844 · MDR key 7433718
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6K0657X
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.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPH EVALUATION OF ONE DEVICE. POTENTIAL JAW MISALIGNMENT WAS OBSERVED FOR A DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. WITHOUT THE PHYSICAL PRODUCT OR ADEQUATE AND QUALIFIED PHOTOGRAPHS THE PRESENCE OF A JAW MISALIGNMENT COULD NOT BE DETERMINED. 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, DURING A PROCEDURE, THE MOUTHS OF THE DISSECTOR WERE OPEN/SPACED AND TRAPEZOIDAL/WARPED. NO PATIENT INJURY.