ENDO DISSECT
Received Apr 17, 2018 · Event occurred Mar 29, 2018
Report 2647580-2018-01872 · MDR key 7437046
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7L1303X
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
POST MARKET VIGILANCE RECEIVED THE DEVICE WITH THE APPROPRIATE PACKAGING IN AN UNDAMAGED CONDITION FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE DEVICE HAS A SLIGHT MISALIGNMENT. FUNCTIONAL TESTING NOTED THAT THE JAWS CLOSED AND ROTATED PROPERLY AS PER INTENDED USE. THE REPORTED CONDITION WAS NOT CONFIRMED. 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 LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS USE AND THERE WAS MAL-ALIGNMENT OF THE JAWS NOTED. SURGEON STATED THAT DEVICE WAS DIFFERENT THAN USUAL IN USING FOR DISSECTION. THE SURGEON STILL USE THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.