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

Model Number 420309-03

Device Problems Device Inoperable (1663); Mechanical Jam (2983)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the tips of the megasturecut needledriver instrument jammed.It won't function.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis found the instrument's grip cables to be broken.One grip close cable was broken at the distal idlers.The idler pulley spun freely and did not exhibit damage.The cable segment was observed to be sticking out at the wrist of the instrument.The other cables at the wrist of the instrument were undamaged.No other damage was found.The customer reported complaint does not in itself constitute a mdr reportable event; however, the broken cable found during failure analysis if to recur could cause or contribute to an adverse event.

• Brand Name: MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
• 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: 3703137
• MDR Text Key: 17389198
• Report Number: 2955842-2014-01811
• 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: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420309-03
• Device Lot Number: M10131101 176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/27/2014
• 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