MalfunctionNAY

SUREFORM 60 STAPLER

Received Dec 5, 2022 · Event occurred Nov 28, 2022

Report MW5113648 · MDR key 15925340

Device

Generic name

System, Surgical, Computer Controlled Instrument

Manufacturer

Intuitive Surgical S. De R.l. De C.v

Catalog number

480460

Lot number

L10220921

Product problems

Communication or Transmission Problem
Output Problem

Patient

48 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

INTUITIVE DAVINCI ROBOTIC STAPLER NOT RECOGNIZED AFTER MULTIPLE USES. FUNCTIONING PROPERLY FOR SEVERAL USES, THEN STOPPED WORKING. NEW STAPLER OBTAINED, NO HARM TO PATIENT. FDA SAFETY REPORT ID# (B)(4).