ENDO DISSECT
Received Feb 27, 2017
Report 2647580-2017-05012 · MDR key 6362487
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6F0225X
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact 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: DURING A PROCEDURE, THE JAWS OF THE DEVICE DID NOT CLOSE LEAVING A GAP. NO PATIENT INJURY.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS NOT USED IN A SURGICAL PROCEDURE THE VISUAL INSPECTION AND MEASUREMENT OF THE DEVICE NOTED THAT THE JAW ALIGNMENT WAS WITHIN SPECIFICATION. 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; THEREFORE, A DEVICE HISTORY RECORD WILL NOT BE PERFORMED. OUR INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE OR ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.