ENDO DISSECT
Received Sep 13, 2018 · Event occurred Aug 22, 2018
Report 2647580-2018-04520 · MDR key 7872468
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P8A0576X
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 A GALLBLADDER PROCEDURE, THE JAW OF THE DEVICE WAS DISLOCATED. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE JAW ALIGNMENT OF DEVICE WAS WITHIN SPECIFICATIONS. JAWS WERE INSPECTED UNDER A MICROSCOPE AND NO PHYSICAL DAMAGE TO THE JAWS WAS FOUND. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A GALLBLADDER PROCEDURE, THE JAW OF THE DEVICE WAS DISLOCATED. THE PRODUCT WAS CHANGED TO RESOLVE THE ISSUE ON ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.