inforMED
MalfunctionGET

ENDO GRASP

Received Dec 27, 2018 · Event occurred Nov 28, 2018

Report 2647580-2018-06320 · MDR key 8199927

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174233

Catalog number

174233

Lot number

P6C0026X

Product problems

  • Material Split, Cut or Torn
  • Material Split, Cut or Torn

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. SHEARING DAMAGE OF THE PLASTIC CABLE SHEATH WAS OBSERVED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHERE AN EXCESSIVE FORCE OR LEVERAGE IS APPLIED TO THE DEVICE WHILE RETRACTING THE CLEVIS ASSEMBLY AND THE CLEVIS BOOT IS SUBSEQUENTLY DAMAGED. THIS SUBSEQUENT DAMAGE MAY RESULT IN IMPROPER RETRACTION AND DEPLOYMENT OF THE JAWS DURING ARTICULATION AND MAY CAUSE SHEARING OF THE PLASTIC CABLE SHEATH. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. 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 CASE OF EXCISION OF MEDIASTINAL LESION AND THORACOSCOPY, BOTH DEVICE HAD THEIR COATING PEELED-OFF AFTER JUST ONE USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.