inforMED
MalfunctionGET

ENDO GRASP

Received Dec 6, 2017 · Event occurred Nov 6, 2017

Report 2647580-2017-08426 · MDR key 7088294

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174233

Catalog number

174233

Lot number

P6L0089X

Product problems

  • Break
  • Break

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. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE SHEATH WAS DAMAGED PROXIMAL 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. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF EXCESSIVE MANIPULATION OF THE DEVICE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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, PRIOR A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A NURSE CHECKED THE DEVICE EXTENDING ITS TIP TO THE STRAIGHT POSITION, HE/SHE FOUND THE TIP BROKEN. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE STATUS OF THE PATIENT IS NO PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.