ENDO DISSECT
Received Apr 6, 2018 · Event occurred Mar 19, 2018
Report 2647580-2018-01725 · MDR key 7403169
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7C1168X
Product problems
- Break
- Difficult to Open or Close
- Break
- Difficult to Open or Close
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES. NO ABNORMALITIES WERE FOUND DURING VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD 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.
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL MANUFACTURERS¿ QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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.
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, BEFORE THE LAPAROSCOPIC POUCH SURGERY, DURING THE PREPARATION PHASE OF THE DEVICE, IT WAS REALIZED THAT THE JAWS OF THE DEVICE WERE SEPARATED/SPLIT, THEREFORE A SECOND DEVICE WAS OPENED, THE DISSECTOR JAWS DID NOT CLOSE AS MUTUAL. THESE DEVICES WERE NOT USED IN THE CASE. THIS PROBLEM WOULD HAVE CAUSED UNWANTED TISSUE DAMAGE AND INJURY. THE CASE WAS COMPLETED BY USING A NEW DEVICE. THERE WAS NO PATIENT INJURY.