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

Model Number 420296-02

Device Problems Break (1069); Malposition of Device (2616)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

It was reported that in central processing, it was identified that wires in the jaw of the large needle driver instrument were broken and hanging out at the distal end.There was no report of fragments falling into a patient.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 cable to be broken at the distal idlers.The idler pulley spun freely and was not damaged.The cable segment stuck out at the wrist of the instrument.The other cables at the wrist of the instrument were undamaged.Failure analysis investigation also found the instrument's distal pulley had mechanical indentations/burrs.There were indentations at the edge of the distal pulley and visible scratches on the surface of the pulley.Failure analysis concluded that the mechanical indentations/burrs damage may be due to mishandling/misuse.No other damage was found.The instruments and accessories user manual 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 in itself constitute a mdr reportable event; however; the broken cable if to recur could cause or contribute to an adverse event.

• Brand Name: LARGE 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: 3765206
• MDR Text Key: 4549643
• Report Number: 2955842-2014-02445
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420296-02
• Device Lot Number: M10131010 582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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