inforMED
MalfunctionGET

ENDO DISSECT

Received Apr 17, 2018 · Event occurred Mar 29, 2018

Report 2647580-2018-01877 · MDR key 7437915

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Lot number

P7K1585X

Product problems

  • Failure to Align
  • Failure to Align

Patient

Not reported

  • 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

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS USE AND THERE WAS MAL-ALIGNMENT OF THE JAWS NOTED. SURGEON STATED THAT DEVICE WAS DIFFERENT THAN USUAL IN USING FOR DISSECTION. THE SURGEON STILL USE THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.