MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420309-01

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci hysterectomy procedure, the mega suturecut needle driver instrument wasn't cutting right.While the surgeon was using, a spring just sprang out on one end and the other end was still attached to the instrument.There were no reports of fragments falling into a patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation found the grip cable broken at the distal clevis hub.The broken cable segment stuck out at the instrument's wrist.The clevis did not exhibit any wear.Other cables at the wrist were not damaged.Failure analysis was unable to perform a cut test due to the broken grip cable.The blades did not exhibit damage.The customer reported complaint does not itself constitute a mdr reportable event; however; the broken cable, could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3920881
• MDR Text Key: 4519533
• Report Number: 2955842-2014-04173
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420309-01
• Device Lot Number: M10130925 395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 75