inforMED
MalfunctionGET

ENDO DISSECT

Received Apr 9, 2018 · Event occurred Mar 21, 2018

Report 2647580-2018-01746 · MDR key 7406862

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P6F0225X

Product problems

  • Failure to Align
  • Positioning Problem
  • Failure to Align
  • Positioning Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. ENGINEERING VERIFIED THAT JAW ALIGNMENT OF DEVICE WAS WITHIN SPECIFICATIONS. ENGINEERING INSPECTED JAWS UNDER A MICROSCOPE AND FOUND NO PHYSICAL DAMAGE TO THE JAWS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. 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, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE IN THE BEGINNING OF THE SURGERY DURING DISSECTION, THE GRASP OR SHEARS DID NOT CLOSE OR CLINCH PROPERLY, THE HANDLES DID NOT BIND AND THE JAWS APPEARED TO BE MAL-ALIGNED. A NEW PRODUCT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.