MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY SPATULA INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420184-06

Device Problem Malposition of Device (2616)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that prior to starting a da vinci surgical procedure, there were wires showing and hanging out at the end of the permanent cautery spatula instrument.There was no allegation of harm or injury to a patient.Nothing reportedly fell into the patient.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was not able to verify the customer reported complaint.Visual inspection did not find any wires hanging out.Failure analysis investigation also found the following unreported damages: the distal end of the main tube had a scratch mark with light material removal.The scratch was short and not axially aligned with the tube.The proximal clevis were broken on both sides of the instrument, measuring.219 x.209 and the broken pieces were not returned with the instrument.Failure analysis concluded that the damage was likely due to mishandling.There were indentations at the edge of the distal pulley.Failure analysis concluded that the indentations were likely due to mishandling.The instrument conductor wire insulation was damaged.The conductor wire insulation was lifted by the grip area and no missing piece was noted.Failure analysis concluded that the damage was likely due to mishandling.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 reportable event; however, the broken main tube material removal and the broken proximal clevis with missing pieces found during failure analysis could likely cause or contribute to an adverse event, if the malfunctions were to recur.

• Brand Name: PERMANENT CAUTERY SPATULA 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: 3917155
• MDR Text Key: 4664520
• Report Number: 2955842-2014-04120
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420184-06
• Device Lot Number: M10131104 219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/17/2014
• 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