ENDO DISSECT
Received Jan 9, 2018 · Event occurred Dec 20, 2017
Report 2647580-2018-00185 · MDR key 7175890
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Product problems
- Break
- Detachment Of Device Component
- Break
- Detachment Of Device Component
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE INSULATION OF THE DEVICE PEELED OFF AFTER APPLYING MONOPOLAR CAUTERY ON VISCERAL PLEURA TISSUE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION : IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN LOBECTOMY, THE INSULATION OF THE DEVICE PEELED OFF AFTER APPLYING MONOPOLAR CAUTERY ON VISCERAL PLEURA TISSUE. THEY STOPPED APPLYING MONOPOLAR CAUTERY AND USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. SHAFT OF THE DEVICE WAS BENT. SLEEVE EXTENDING BEYOND AND FROM DISTAL END OF SHAFT WAS RUPTURED WHERE PROXIMAL ENDS OF JAWS PIVOT. NO BURNING OR CHARRING WAS OBSERVED. 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. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHEN IMPROPER OR EXCESSIVE FORCE IS EXERTED ON THE DEVICE RESULTING IN THE BENDING OF THE SHAFT WHICH IN TURN CAUSES DISLOCATION AND CHANGE IN CONFIGURATION OF THE JAW. THIS CHANGE IN THE CONFIGURATION OF THE JAW CAUSES IT TO PUSH AGAINST AND RUPTURE THE SLEEVE WHICH EXTENDS BEYOND THE DISTAL END OF SHAFT . THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.