ENDO DISSECT
Received Dec 5, 2017 · Event occurred Nov 21, 2017
Report 2647580-2017-08337 · MDR key 7084668
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P5G0188X
Product problems
- Product Quality Problem
- Difficult to Open or Close
- Product Quality Problem
- 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
THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT THE FIRST ATTEMPT TO CATCH THE TISSUE, THE DISSECTOR DID NOT CLOSE PROPERLY, WHEN THE DEVICE WAS REVIEWED, IT WAS DETECTED THAT IT WAS OPEN AT THE PLACE WHERE WAS THE UNION OF THE STEMWITH THE CLAMP. A NEW DISSECTOR WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.
Additional Manufacturer Narrative
POST MARKET VIGILANCE (PMV) LED AN IMAGE EVALUATION OF ONE DEVICE. DEVICE WAS SPLITTING APART WHERE SHAFT MET THE BODY OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. AS A PHYSICAL DEVICE WAS NOT RECEIVED, THE DEVICE COULD NOT BE ADEQUATELY EVALUATED TO DETERMINE THE ROOT CAUSE OF THE REPORTED CONDITION. 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.