inforMED
MalfunctionGET

ENDO DISSECT

Received Jan 16, 2018 · Event occurred Dec 26, 2017

Report 2647580-2018-00306 · MDR key 7193965

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P7C1168X

Product problems

  • Mechanical Problem
  • Failure to Align
  • Physical Resistance
  • Mechanical Problem
  • Failure to Align
  • Physical Resistance

Patient

52 YR

  • 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.

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. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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: OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, NOTICED THAT THE JAWS WERE NOT CLOSED PROPERLY. THE TWO JAWS DID NOT COME UP / COINCIDE EXACTLY TO EACH OTHER. THE DEVICE DID NOT GRASP PROPERLY. THE DEVICE WAS NOT USED ON THE PATIENT. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, REPLACED WITH A NEW DEVICE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS REPORTED AS ALIVE, NO INJURY.