inforMED
MalfunctionGET

ENDO DISSECT

Received Oct 23, 2018 · Event occurred Sep 20, 2018

Report 2647580-2018-05126 · MDR key 7995287

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P7E0416X

Product problems

  • Break
  • Noise, Audible
  • Break
  • Noise, Audible

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. VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. 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 LAPAROCOPIC GASTRECTOMY PROCEDURE, THE DEVICE TIP BROKE WITH CRACKING SOUND WHILE CHECKING FOR OPENING AND CLOSING AFTER REMOVING THE DEVICE FROM THE PACKAGE. THE LEVER OF THE OTHER DEVICE WAS TOO HARD TO OPERATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.