inforMED
MalfunctionGET

ENDO GRASP

Received Sep 11, 2017 · Event occurred Aug 14, 2017

Report 2647580-2017-06513 · MDR key 6856042

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174233

Catalog number

174233

Lot number

P6L0090X

Product problems

  • Difficult to Open or Close
  • Difficult to Open or Close

Patient

Not reported

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

Narrative

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE USER ATTEMPTED TO OPEN THE JAWS OF THE DEVICE IN THE PATIENT'S CAVITY, THE JAW DID NOT OPEN EVEN WHEN RELEASING THE RATCHET. THE USER USED A NEW DEVICE, BUT THE JAW DID NOT OPEN AS SAME. THE SAME LOT PRODUCTS WERE REPLACED IN THE HOSPITAL. THE STATUS OF THE PATIENT IS NO PROBLEM.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION ONE DEVICE. VISUAL FUNCTIONAL INDICATED NO ABNORMALITIES. 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. CORRECTION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.