ENDO DISSECT
Received Mar 2, 2018 · Event occurred Feb 13, 2018
Report 2647580-2018-01139 · MDR key 7310634
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7L0412X
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING LAPAROSCOPY, THE INSTRUMENTS WERE FOUND FAULTY UPON OPENING THE STERILE PACKAGE AND NOT UTILIZED. THEY NOTICED THAT THE JAWS WERE MISALIGNED, SO, THEY SET IT ASIDE AND GRABBED A NEW ONE. HOWEVER, UPON OPENING THEY DISCOVERED THAT THE JAWS WERE MISALIGNED AS WELL AND SET IT ASIDE. ACCORDINGLY, THEY OPENED A THIRD DEVICE TO COMPLETE THE CASE. AS REPORTED, THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
ADDITIONAL: (FIRST NAME, LAST NAME, EMAIL, PHONE AND FAX #). 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.