MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420179-12

Device Problem Malposition of Device (2616)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the customer noted that the monopolar curved scissors instrument tips would not meet.There was no report of fragments falling into a patient.There was no allegation of any harm, injury, or adverse outcome to a patient.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was unable to confirm the customer reported failure mode.The instrument was place on an in-house da vinci system and it was able to perform cut test.No trouble was found and blades did not exhibit any damage.An additional observation not reported by site was that the instrument's tube extension exhibited pad printing removed.The instrument had a scratch on the tube extension that had removed the pad printing.The area damaged measured approximately.145.Evidence not conclusive, but pad printing removed damage may be due to likely mishandling/misuse.No other damage was found.The endowrist instruments instructions for use (ifu) specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not itself constitute a mdr reportable event, in a fragment-causing failure (such as a cable failure, a crimp separating from a cable etc.) for the mcs instrument the tip cover accessory will hold such fragments inside the tip cover, preventing loss into the patient during the removal of the instrument.Because the tip cover acts as a barrier, these failures, which might be reportable in other instruments, are not reportable events for the mcs instrument; however, the pad printing removed, which was found during failure analysis evaluation could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: MONOPOLAR CURVED SCISSORS INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 3922090
• MDR Text Key: 4664665
• Report Number: 2955842-2014-04180
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179-12
• Device Lot Number: M10131105 220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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