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

Model Number 420309-01

Device Problems Material Frayed (1262); 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 during the reprocessing of a mega suturecut needle driver instrument, the cable was frayed.Threads were hanging out at the distal end.Nothing reportedly fell into a patient and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation found one grip close cable broken at the distal idlers.The idler pulley spun freely and did not exhibit damage.The cable segment stuck out at the instrument's wrist.Other cables at the wrist were not damaged.No other damage was found.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: 3782207
• MDR Text Key: 4437821
• Report Number: 2955842-2014-02686
• 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: 04/30/2014
• 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: M10121024 032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• 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: 10/01/2012
• 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